From Medscape Education Clinical Briefs
Emma Hitt, Yael Waknine
December 22, 2010 — Accidental ingestion of benzonatate (Tessalon) by children younger than 10 years can result in serious adverse effects or death, the US Food and Drug Administration (FDA) announced.
Benzonatate, a round, liquid-filled gelatin capsule, is approved for symptomatic relief of cough in children older than 10 years but may represent a danger to younger children because of its candy-like appearance.
"The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose," Carol Holquist, RPh, director of the FDA's Division of Medication Error Prevention and Analysis, said in a news release. "Benzonatate should be kept in a child-resistant container and stored out of reach of children," she added.
Adverse events associated with ingestion of benzonatate include restlessness, tremors, convulsions, coma, and cardiac arrest, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program. Signs and symptoms of overdose can occur within 15 to 20 minutes of ingestion. Deaths reported in children have occurred within hours of accidental ingestion.
The FDA's Adverse Event Reporting System database identified 31 cases of overdose associated with benzonatate (median age, 18 years; range 1 - 66 years) between 1982 and May 2010.
Of those 31 cases, 7 cases of accidental ingestion were associated with benzonatate in children younger than 10 years. Of those 7 cases, 5 ingestions of as little as 1 capsule resulted in death in children younger than 3 years. Two patients, aged 12 months and 4 years, were hospitalized because of accidental benzonatate ingestion but survived.
"The safety and effectiveness of benzonatate in children younger than 10 years has not been established," according to the FDA news release.
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn healthcare professionals about accidental ingestion resulting in overdose and death in children younger than 10 years.
Additional Safety Tips
* Benzonatate capsules should be kept in a child-resistant container and stored out of sight and reach of children at all times. Medication should never be referred to as candy.
* Be aware that signs and symptoms of benzonatate overdose can occur within 15 to 20 minutes of ingestion and include restlessness, tremors, convulsions, coma, and cardiac arrest.
* Benzonatate capsules should be swallowed whole and not broken, chewed, dissolved, or crushed. Excessive absorption of the local anesthetic in oral mucosa can cause numbing of the mouth and throat, posing a choking hazard.
* If numbness or tingling of the mouth, tongue, throat, or face occurs, eating and drinking should be avoided until the condition resolves. Medical attention should be sought if symptoms persist or worsen.
* Benzonatate overdose has been reported in adults and adolescents. Patients should be aware that the maximum dose to be taken at any one time is 200 mg and the total daily dose should not exceed 600 mg. Missed doses should be skipped and the next dose taken as scheduled.
* Patients and caregivers should properly dispose of unneeded or expired medication by making it less appealing to children and pets (eg, mixing the medication with coffee grounds/kitty litter) and unrecognizable to others with access to trash. To prevent unintentional spillage from garbage bags, a sealable bag, empty can with tight lid, or other container should be used.
Healthcare professionals should advise parents and caretakers to call the Poison Control Center at 1-800-222-1222 and to seek medical attention immediately if a child accidentally ingests benzonatate.
More information about this warning can be found on the FDA Web site.
Clinical Implications
* Benzonatate is marketed as a round, liquid-filled gelatin capsule that resembles candy, potentially leading to accidental ingestion by children younger than 10 years. Overdose symptoms can occur within 15 to 20 minutes and include restlessness, tremors, convulsions, coma, and cardiac arrest; death has been reported within hours.
* Benzonatate capsules are indicated for symptomatic cough relief in patients older than 10 years. The pills must be swallowed whole and not broken, chewed, dissolved, or crushed. No more than 200 mg benzonatate should be taken at any 1 time, and the maximum daily dose is 600 mg; missed doses should be skipped. In the event of oral, throat, or facial numbness, food and drink should be avoided until symptoms resolve.
* Benzonatate capsules should be kept in child-resistant containers out of sight and reach of children. Unneeded or expired medication should be disposed of in a manner that renders it unappealing and unrecognizable to children, pets, and those with access to trash.
Tuesday, January 4, 2011
Parents' Assessment of Earache Pain in Children May Be Unreliable
From Medscape Medical News
Laurie Barclay, MD
January 3, 2011 — Parents' assessment of earache pain in preverbal children with presumed acute otitis media (AOM) might be unreliable, according to the results of a study reported in the December 2010 issue of the Journal of Pain.
"In preverbal children, who constitute the majority of children with AOM, it is not clear how parents determine whether their child is having otalgia," write Nader Shaikh, MD, MPH, from the Division of General Academic Pediatrics, University of Pittsburgh School of Medicine in Pennsylvania, and colleagues. "Specifically, it is unclear which of the symptoms of AOM impacts parental pain assessment the most. Information regarding specific symptoms with high levels of association with otalgia can help clinicians focus their history taking."
The study goal was to assess how parents of preverbal children decide if their child is experiencing otalgia. The investigators wrote 8 case scenarios describing a 1-year-old child with AOM using various combinations of 6 observable behaviors: fussiness, ear tugging, eating less, fever, difficulty sleeping, and reduced play.
Using a visual analog scale, 69 parents of children with a history of AOM who attended an ambulatory clinic for well or sick visits were asked to score the pain level for each constructed case. Although each of the 6 observable behaviors was significantly associated with increased pain scores (P < .0001), ear tugging and fussiness had the greatest effect on the parents' pain ratings.
Factors associated with higher reported pain levels were higher level of parental education (P = .007) and private insurance (P = .001).
"Parents of preverbal children with acute otitis media use observable behaviors to determine their child's pain level," the study authors write. "Interpretation of symptoms, however, appears to be influenced by socioeconomic status. Thus, we question the utility of using a 1-item parental pain scale in clinical trials that include preverbal children."
Limitations of this study include the relatively small sample size and the homogeneous study population. The investigators also note that parents' responses to scenarios about a hypothetical child could have differed from their real-life responses to their own child.
"In the most recent guidelines on the measurement of pain in pediatric clinical trials, all pain measures recommended were multi-item scales: Use of global single-item scales for the measurement of pain in preverbal children was not endorsed," the study authors conclude. "In a clinical setting, we feel that asking parents about specific observable behaviors, such as ear tugging and fussiness, would nicely complement a general question about ear pain. This would ensure that clinicians are aware of the specific symptoms present and at the same time fully understand and address parental concerns about their child's condition."
The National Center for Research Resources supported this study. Two of the study authors are employees of Novartis Oncology.
J Pain. 2010;11:1291-1294. Abstract
Laurie Barclay, MD
January 3, 2011 — Parents' assessment of earache pain in preverbal children with presumed acute otitis media (AOM) might be unreliable, according to the results of a study reported in the December 2010 issue of the Journal of Pain.
"In preverbal children, who constitute the majority of children with AOM, it is not clear how parents determine whether their child is having otalgia," write Nader Shaikh, MD, MPH, from the Division of General Academic Pediatrics, University of Pittsburgh School of Medicine in Pennsylvania, and colleagues. "Specifically, it is unclear which of the symptoms of AOM impacts parental pain assessment the most. Information regarding specific symptoms with high levels of association with otalgia can help clinicians focus their history taking."
The study goal was to assess how parents of preverbal children decide if their child is experiencing otalgia. The investigators wrote 8 case scenarios describing a 1-year-old child with AOM using various combinations of 6 observable behaviors: fussiness, ear tugging, eating less, fever, difficulty sleeping, and reduced play.
Using a visual analog scale, 69 parents of children with a history of AOM who attended an ambulatory clinic for well or sick visits were asked to score the pain level for each constructed case. Although each of the 6 observable behaviors was significantly associated with increased pain scores (P < .0001), ear tugging and fussiness had the greatest effect on the parents' pain ratings.
Factors associated with higher reported pain levels were higher level of parental education (P = .007) and private insurance (P = .001).
"Parents of preverbal children with acute otitis media use observable behaviors to determine their child's pain level," the study authors write. "Interpretation of symptoms, however, appears to be influenced by socioeconomic status. Thus, we question the utility of using a 1-item parental pain scale in clinical trials that include preverbal children."
Limitations of this study include the relatively small sample size and the homogeneous study population. The investigators also note that parents' responses to scenarios about a hypothetical child could have differed from their real-life responses to their own child.
"In the most recent guidelines on the measurement of pain in pediatric clinical trials, all pain measures recommended were multi-item scales: Use of global single-item scales for the measurement of pain in preverbal children was not endorsed," the study authors conclude. "In a clinical setting, we feel that asking parents about specific observable behaviors, such as ear tugging and fussiness, would nicely complement a general question about ear pain. This would ensure that clinicians are aware of the specific symptoms present and at the same time fully understand and address parental concerns about their child's condition."
The National Center for Research Resources supported this study. Two of the study authors are employees of Novartis Oncology.
J Pain. 2010;11:1291-1294. Abstract
Risk for Thyroid Cancer Persists Decades After Childhood Radiation
From Medscape Medical News > Oncology
Fran Lowry
January 3, 2011 — People who received radiation for an enlarged thymus when they were babies have an increased risk of developing thyroid cancer that lasts throughout their lives, according to a new study published in the December issue of Radiation Research.
The study results might provide some insight as to why the rates of thyroid cancer continue to rise, lead author Jacob Adams, MD, from the University of Rochester in New York, told Medscape Medical News. "They also mean that the risk for thyroid cancer is going to be life long. We can't ignore that fact."
The finding comes from an update of a longitudinal study of individuals who were irradiated for thymic enlargement with lower doses of radiation (median, 0.95 Gy; mean, 1.29 Gy) between 1926 and 1957 and who were followed until 1987 for the occurrence of cancer.
The subjects were part of the Hempelmann cohort; Louis Hempelmann, MD, began the study in 1951 at the University of Rochester.
At final follow-up, when the individuals were, on average, 38 years old, those exposed to lower-dose thymic radiation had a risk for thyroid cancer that was roughly 19 times higher than that of their unexposed siblings and 24.3 times higher than that of unrelated subjects of the same age and sex living in New York State.
Irradiating the thymus gland is no longer done, but in the early part of the last century, a misconception about the normal size range of infant thymus glands and the mistaken belief that an enlarged thymus could lead to status lymphaticus and suffocation caused thousands of infants and children to be exposed to thymic radiation.
Dr. Adams and his team sought to determine if the increased cancer risk seen in the Hempelmann cohort persisted. From 2004 to 2008, they resurveyed the surviving members of the cohort, as well as their unexposed siblings. The mean age of the irradiated subjects at the second survey was 58 years.
The researchers found that the risk of developing thyroid cancer was still higher for irradiated subjects than for their siblings. Thyroid cancer occurred in 50 of the 1303 irradiated subjects, who received a mean thyroid dose of 1.29 Gy, and in only 13 of the 1768 nonirradiated siblings.
After adjustment for age, Jewish religion, sex, and history of goiter, the rate ratio for thyroid cancer was 5.6 (95% confidence interval [CI], 3.1 to 10.8).
The risk was also dose dependent. The adjusted excess relative risk per gray was 3.2 (95% CI, 1.5 to 6.6) and the adjusted excess absolute risk per gray was 2.2 cases (95% CI, 1.4 to 3.2) per 10,000 person-years.
"This was the longest longitudinal follow-up of any cohort exposed to chest radiotherapy. The results clearly show that the risk of thyroid cancer remains for a very long time," Dr. Adams said. "They also suggest that young children undergoing multiple [computed tomography] scans that expose the thyroid to radiation are at increased risk for thyroid cancer well into adulthood. Even as we cut radiation doses, we can't assume that we're going to eliminate cancer risk, in this case thyroid cancer risk. We're going to decrease it, but we're probably never going to eliminate it."
Even when you're old, you're not out of the woods.
Commenting on this study for Medscape Medical News, Albert Blumberg, MD, chair of the American College of Radiology Commission on Radiation Oncology, and vice chair of the Department of Radiation Oncology at the Greater Baltimore Medical Center in Maryland, said: "It just reinforces things we've known about for a long time. We really ought to think 2, 3, 4, and 5 times before we irradiate anybody for a benign condition."
Dr. Blumberg said that radiologists are cognizant of the importance of using as little radiation as possible in appropriate settings and that the profession has recently launched initiatives to increase awareness about the issue among its members and the public.
"This study reinforces the importance of the efforts that have been underway — organized by the American College of Radiology, the Society for Pediatric Radiology, and other concerned groups — with the Image Gently campaign for children. This has led to the Image Wisely campaign for adults, which was inaugurated this fall," he said.
"The bottom line is before we order scans willy-nilly on anybody, regardless of their age, we need to think twice. Do we really need the study? How can we do a requested study in the most expeditious fashion with the least radiation dose to be able to interpret the study correctly? Because, as this article says, you're not out of the woods even 58 years after the fact."
Dr. Blumberg added that "no radiation comes without a price. Radiologists need to be participating fully in the Image Gently and Image Wisely campaigns and to be mindful in our own personal practices of what we are doing, because there's no free lunch here. Every time you do a study on somebody, it has an implication."
Dr. Adams and Dr. Blumberg have disclosed no relevant financial relationships.
Radiat Res. 2010:174:753-762. Abstract
Fran Lowry
January 3, 2011 — People who received radiation for an enlarged thymus when they were babies have an increased risk of developing thyroid cancer that lasts throughout their lives, according to a new study published in the December issue of Radiation Research.
The study results might provide some insight as to why the rates of thyroid cancer continue to rise, lead author Jacob Adams, MD, from the University of Rochester in New York, told Medscape Medical News. "They also mean that the risk for thyroid cancer is going to be life long. We can't ignore that fact."
The finding comes from an update of a longitudinal study of individuals who were irradiated for thymic enlargement with lower doses of radiation (median, 0.95 Gy; mean, 1.29 Gy) between 1926 and 1957 and who were followed until 1987 for the occurrence of cancer.
The subjects were part of the Hempelmann cohort; Louis Hempelmann, MD, began the study in 1951 at the University of Rochester.
At final follow-up, when the individuals were, on average, 38 years old, those exposed to lower-dose thymic radiation had a risk for thyroid cancer that was roughly 19 times higher than that of their unexposed siblings and 24.3 times higher than that of unrelated subjects of the same age and sex living in New York State.
Irradiating the thymus gland is no longer done, but in the early part of the last century, a misconception about the normal size range of infant thymus glands and the mistaken belief that an enlarged thymus could lead to status lymphaticus and suffocation caused thousands of infants and children to be exposed to thymic radiation.
Dr. Adams and his team sought to determine if the increased cancer risk seen in the Hempelmann cohort persisted. From 2004 to 2008, they resurveyed the surviving members of the cohort, as well as their unexposed siblings. The mean age of the irradiated subjects at the second survey was 58 years.
The researchers found that the risk of developing thyroid cancer was still higher for irradiated subjects than for their siblings. Thyroid cancer occurred in 50 of the 1303 irradiated subjects, who received a mean thyroid dose of 1.29 Gy, and in only 13 of the 1768 nonirradiated siblings.
After adjustment for age, Jewish religion, sex, and history of goiter, the rate ratio for thyroid cancer was 5.6 (95% confidence interval [CI], 3.1 to 10.8).
The risk was also dose dependent. The adjusted excess relative risk per gray was 3.2 (95% CI, 1.5 to 6.6) and the adjusted excess absolute risk per gray was 2.2 cases (95% CI, 1.4 to 3.2) per 10,000 person-years.
"This was the longest longitudinal follow-up of any cohort exposed to chest radiotherapy. The results clearly show that the risk of thyroid cancer remains for a very long time," Dr. Adams said. "They also suggest that young children undergoing multiple [computed tomography] scans that expose the thyroid to radiation are at increased risk for thyroid cancer well into adulthood. Even as we cut radiation doses, we can't assume that we're going to eliminate cancer risk, in this case thyroid cancer risk. We're going to decrease it, but we're probably never going to eliminate it."
Even when you're old, you're not out of the woods.
Commenting on this study for Medscape Medical News, Albert Blumberg, MD, chair of the American College of Radiology Commission on Radiation Oncology, and vice chair of the Department of Radiation Oncology at the Greater Baltimore Medical Center in Maryland, said: "It just reinforces things we've known about for a long time. We really ought to think 2, 3, 4, and 5 times before we irradiate anybody for a benign condition."
Dr. Blumberg said that radiologists are cognizant of the importance of using as little radiation as possible in appropriate settings and that the profession has recently launched initiatives to increase awareness about the issue among its members and the public.
"This study reinforces the importance of the efforts that have been underway — organized by the American College of Radiology, the Society for Pediatric Radiology, and other concerned groups — with the Image Gently campaign for children. This has led to the Image Wisely campaign for adults, which was inaugurated this fall," he said.
"The bottom line is before we order scans willy-nilly on anybody, regardless of their age, we need to think twice. Do we really need the study? How can we do a requested study in the most expeditious fashion with the least radiation dose to be able to interpret the study correctly? Because, as this article says, you're not out of the woods even 58 years after the fact."
Dr. Blumberg added that "no radiation comes without a price. Radiologists need to be participating fully in the Image Gently and Image Wisely campaigns and to be mindful in our own personal practices of what we are doing, because there's no free lunch here. Every time you do a study on somebody, it has an implication."
Dr. Adams and Dr. Blumberg have disclosed no relevant financial relationships.
Radiat Res. 2010:174:753-762. Abstract
Monday, January 3, 2011
AAP Issues Guidelines on Bone Densitometry in Children and Adolescents
From Medscape Medical News
Laurie Barclay, MD
January 3, 2011 — The American Academy of Pediatrics (AAP) has issued clinical guidelines regarding the use, interpretation, harms, and costs of bone densitometry in children and adolescents. The new recommendations are reported online December 27, 2010, in a clinical report in Pediatrics.
"Concern for bone fragility in children and adolescents has led to increased interest in bone densitometry," write Laura K. Bachrach, MD; Irene N. Sills, MD; and colleagues from the AAP Section on Endocrinology. "Pediatric patients with genetic and acquired chronic diseases, immobility, and inadequate nutrition may fail to achieve the expected gains in bone size, mass, and strength, which leaves them vulnerable to fracture. In older adults, bone densitometry has been shown to predict fracture risk and reflect response to therapy, [but] the role of densitometry in the management of children at risk of bone fragility is less certain."
Recommendations highlighted in the AAP clinical report were based on consensus statements developed by an international panel of bone experts convened at the 2007 Pediatric Position Development Conference of the International Society of Clinical Densitometry. Whenever possible, the recommendations were evidence based, but others reflect expert consensus because existing evidence was insufficient.
Indications for Bone Densitometry in Children
Specific recommendations regarding indications for use of bone densitometry in the pediatric population include the following:
* Dual-energy x-ray absorptiometry (DXA) of the lumbar spine and total body is the recommended test to determine bone density in children because of high availability, reproducibility, speed, low levels of radiation exposure, and availability of a pediatric reference database.
* Children with primary bone disorders (idiopathic juvenile osteoporosis and osteogenesis imperfecta) and secondary disorders linked to an increased risk for fracture should undergo densitometry when they are first seen and before bone-active therapy is started. Secondary conditions include chronic inflammatory diseases, immobilization for long periods, endocrine or hematologic diseases, and cancer and associated treatments that adversely affect bone.
* Children with a history of clinically significant fracture (1 lower extremity long-bone fracture, ≥ 2 upper extremity long-bone fractures, or vertebral fracture after minimal or no trauma) should undergo DXA scanning. Bone mineral density (BMD) measurement may be indicated, depending on patient age at fracture, severity of any underlying conditions, associated risk factors, exposure to ionizing radiation or drugs adversely affecting bone, exposure, family history, number of fractures, and trauma intensity, with low trauma fractures defined as those involving a fall from standing height or less.
* In children, the lumbar spine and total body (excluding the cranium, if possible) are the preferred sites for DXA testing. Children with contractures may need to be tested at the lateral distal aspect of the femur, and those with metal hardware may need to be tested at other sites for children.
* Although 6 months should normally elapse before densitometry testing is repeated, it might be appropriate in some cases to wait at least 1 year.
Interpretation of Results
Specific recommendations concerning interpretation of results for use of bone densitometry in the pediatric population are as follows:
* In children, suggested diagnostic criteria for osteoporosis are a clinically significant history of fracture and low bone mass with bone mineral content (BMC; in grams) or BMD (in grams per centimeter squared) z score of more than 2 SDs below that expected from DXA reference data for healthy persons of similar age, sex, and race or ethnicity, if possible. Such data are available for children and teenagers but not for infants. For children with chronic illness or delayed puberty, BMD should be adjusted based on height or should be compared with reference data specific for age, sex, and height.
* BMC, BMD, and estimated volumetric BMD are more likely to be lower in healthy children with a history of fractures vs those with no history of fractures.
* Data regarding the association between low bone mass and fracture risk are limited for children with chronic illness.
Risks and Costs
Specific recommendations regarding risks and costs of bone densitometry in the pediatric population include the following:
* Children undergoing spine and total body DXA may be exposed to 5 to 6 μSv of ionizing radiation, which is not known to be associated with health risk.
* If DXA data are not interpreted by skilled professionals at pediatric densitometry centers, there is a potential risk for misdiagnosis, including a high percentage of errors involving a misdiagnosis of osteoporosis on the basis of inappropriate use of a T score.
* Errors in DXA interpretation may result in avoidable parental concern and in expensive and unnecessary use of drugs and restrictions on physical activity.
"DXA has been established as a valuable tool as part of a comprehensive skeletal assessment of children and teenagers but not yet of infants," the guideline authors write. "Acquiring and interpreting densitometry data from younger patients remains challenging and should be performed in experienced pediatric densitometry centers."
"Panels of pediatric experts have set standards for when and how to perform DXA scans on the basis of the best available data," the guideline authors conclude. "Ongoing research will serve to refine the best modalities for assessing the bone strength of children and to determine the key clinical variables that influence fracture risk independent of bone."
The AAP supported development of this clinical report and evaluated any potential conflicts of interest of its authors.
Laurie Barclay, MD
January 3, 2011 — The American Academy of Pediatrics (AAP) has issued clinical guidelines regarding the use, interpretation, harms, and costs of bone densitometry in children and adolescents. The new recommendations are reported online December 27, 2010, in a clinical report in Pediatrics.
"Concern for bone fragility in children and adolescents has led to increased interest in bone densitometry," write Laura K. Bachrach, MD; Irene N. Sills, MD; and colleagues from the AAP Section on Endocrinology. "Pediatric patients with genetic and acquired chronic diseases, immobility, and inadequate nutrition may fail to achieve the expected gains in bone size, mass, and strength, which leaves them vulnerable to fracture. In older adults, bone densitometry has been shown to predict fracture risk and reflect response to therapy, [but] the role of densitometry in the management of children at risk of bone fragility is less certain."
Recommendations highlighted in the AAP clinical report were based on consensus statements developed by an international panel of bone experts convened at the 2007 Pediatric Position Development Conference of the International Society of Clinical Densitometry. Whenever possible, the recommendations were evidence based, but others reflect expert consensus because existing evidence was insufficient.
Indications for Bone Densitometry in Children
Specific recommendations regarding indications for use of bone densitometry in the pediatric population include the following:
* Dual-energy x-ray absorptiometry (DXA) of the lumbar spine and total body is the recommended test to determine bone density in children because of high availability, reproducibility, speed, low levels of radiation exposure, and availability of a pediatric reference database.
* Children with primary bone disorders (idiopathic juvenile osteoporosis and osteogenesis imperfecta) and secondary disorders linked to an increased risk for fracture should undergo densitometry when they are first seen and before bone-active therapy is started. Secondary conditions include chronic inflammatory diseases, immobilization for long periods, endocrine or hematologic diseases, and cancer and associated treatments that adversely affect bone.
* Children with a history of clinically significant fracture (1 lower extremity long-bone fracture, ≥ 2 upper extremity long-bone fractures, or vertebral fracture after minimal or no trauma) should undergo DXA scanning. Bone mineral density (BMD) measurement may be indicated, depending on patient age at fracture, severity of any underlying conditions, associated risk factors, exposure to ionizing radiation or drugs adversely affecting bone, exposure, family history, number of fractures, and trauma intensity, with low trauma fractures defined as those involving a fall from standing height or less.
* In children, the lumbar spine and total body (excluding the cranium, if possible) are the preferred sites for DXA testing. Children with contractures may need to be tested at the lateral distal aspect of the femur, and those with metal hardware may need to be tested at other sites for children.
* Although 6 months should normally elapse before densitometry testing is repeated, it might be appropriate in some cases to wait at least 1 year.
Interpretation of Results
Specific recommendations concerning interpretation of results for use of bone densitometry in the pediatric population are as follows:
* In children, suggested diagnostic criteria for osteoporosis are a clinically significant history of fracture and low bone mass with bone mineral content (BMC; in grams) or BMD (in grams per centimeter squared) z score of more than 2 SDs below that expected from DXA reference data for healthy persons of similar age, sex, and race or ethnicity, if possible. Such data are available for children and teenagers but not for infants. For children with chronic illness or delayed puberty, BMD should be adjusted based on height or should be compared with reference data specific for age, sex, and height.
* BMC, BMD, and estimated volumetric BMD are more likely to be lower in healthy children with a history of fractures vs those with no history of fractures.
* Data regarding the association between low bone mass and fracture risk are limited for children with chronic illness.
Risks and Costs
Specific recommendations regarding risks and costs of bone densitometry in the pediatric population include the following:
* Children undergoing spine and total body DXA may be exposed to 5 to 6 μSv of ionizing radiation, which is not known to be associated with health risk.
* If DXA data are not interpreted by skilled professionals at pediatric densitometry centers, there is a potential risk for misdiagnosis, including a high percentage of errors involving a misdiagnosis of osteoporosis on the basis of inappropriate use of a T score.
* Errors in DXA interpretation may result in avoidable parental concern and in expensive and unnecessary use of drugs and restrictions on physical activity.
"DXA has been established as a valuable tool as part of a comprehensive skeletal assessment of children and teenagers but not yet of infants," the guideline authors write. "Acquiring and interpreting densitometry data from younger patients remains challenging and should be performed in experienced pediatric densitometry centers."
"Panels of pediatric experts have set standards for when and how to perform DXA scans on the basis of the best available data," the guideline authors conclude. "Ongoing research will serve to refine the best modalities for assessing the bone strength of children and to determine the key clinical variables that influence fracture risk independent of bone."
The AAP supported development of this clinical report and evaluated any potential conflicts of interest of its authors.
Clinical Practice Guideline Issued for Tonsillectomy in Children
From Medscape Medical News
Laurie Barclay, MD
January 3, 2011 — The prevalence of tonsillectomy, the associated morbidity, and the availability of hundreds of randomized clinical trials evaluating associated interventions create a pressing need for evidence-based guidance to aid clinicians, according to the multidisciplinary Clinical Practice Guideline: Tonsillectomy in Children, published online January 3, 2011, in Otolaryngology–Head and Neck Surgery.
"Over half a million tonsillectomies are done every year in the United States," said guideline coauthor Richard M. Rosenfeld, MD, MPH, from SUNY Downstate Medical Center and Long Island College Hospital in Brooklyn, New York, in a news release. "The tonsillectomy guideline will empower doctors and parents to make the best decisions, resulting in safer surgery and improved quality of life for children who suffer from large or infected tonsils."
The new guideline, which is intended for all clinicians in any setting who care for children 1 to 18 years old in whom tonsillectomy is being considered, offers evidence-based recommendations on identifying children who are the best candidates for tonsillectomy, and on preoperative, intraoperative, and postoperative care and management. Other objectives of this guideline include highlighting the need for evaluation and intervention in special populations, improving counseling and education for families, describing management options for patients with modifying factors, reducing inappropriate or unnecessary variations in care, and discussing the significant public health implications of tonsillectomy.
The definition of tonsillectomy is a surgical procedure in which the peritonsillar space between the tonsil capsule and the muscular wall is dissected to completely remove the tonsil, including its capsule. The term often refers to tonsillectomy with adenoidectomy, especially in relationship to sleep-disordered breathing (SDB) or other contexts where adenoidectomy is appropriate.
SDB refers to a continuum of obstructive disorders ranging in severity from primary snoring to obstructive sleep apnea (OSA). SDB is characterized by abnormalities of respiratory pattern or of the adequacy of ventilation during sleep, as well as by associated daytime symptoms such as excessive sleepiness, inattention, poor concentration, and hyperactivity.
Indications for tonsillectomy include recurrent throat infections and SDB, both of which can significantly impair childhood health and quality of life (QoL). Throat infection, which includes strep throat and acute tonsillitis, pharyngitis, adenotonsillitis, or tonsillopharyngitis, is defined as sore throat caused by viral or bacterial infection of the pharynx, palatine tonsils, or both, which may or may not be culture positive for group A streptococcus.
"The importance of tonsillectomy as an intervention relates to its documented benefit on child QoL," the guidelines authors write. "For example, when compared with healthy children, children with recurrent throat infections have more bodily pain and poorer general health and physical functioning. Tonsillectomy may improve QoL by reducing throat infections, health care provider visits, and the need for antibiotic therapy."
SDB in children is also associated with cognitive and behavioral impairment that usually improves after tonsillectomy, as do QoL, sleep disturbance, and vocal quality. The potential benefits of tonsillectomy must be weighed against possible surgical complications, including throat pain; postoperative nausea and vomiting; delayed feeding; voice changes; hemorrhage; and, rarely, death.
Guideline Recommendations
Specific recommendations included in the clinical practice guideline are as follows:
* Watchful waiting for recurrent throat infection is recommended if there have been fewer than 7 episodes in the previous year, fewer than 5 episodes per year in the previous 2 years, or fewer than 3 episodes per year in the previous 3 years (statement 1).
* Tonsillectomy may be an option for recurrent throat infection with a frequency of at least 7 episodes in the previous year, at least 5 episodes per year for 2 years, or at least 3 episodes per year for 3 years, provided that the medical record documents each episode of sore throat and the presence of at least one of the following: temperature of more than 38.3°C, cervical adenopathy, tonsillar exudate, or positive test result for group A β-hemolytic streptococcus (statement 2).
* Children with recurrent throat infection who do not meet the criteria in statement 2 may have modifying factors favoring tonsillectomy, including but not limited to multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyngitis and adenitis, or a history of peritonsillar abscess (statement 3).
* Clinicians should ask caregivers of children with SDB and tonsillar hypertrophy about comorbid conditions that might improve after tonsillectomy, such as growth retardation, poor school performance, enuresis, and behavioral problems (statement 4).
* Caregivers of children with abnormal polysomnography results who also have tonsillar hypertrophy and SDB should be counseled about tonsillectomy as a means to improve health issues related to SDB (statement 5).
* Caregivers should be informed that SDB may persist or recur after tonsillectomy and may require further management (statement 6).
* A single, intraoperative dose of intravenous dexamethasone should be given to children undergoing tonsillectomy (statement 7; strong recommendation).
* Clinicians should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillectomy (statement 8; strong recommendation).
* Clinicians should advocate for pain management after tonsillectomy and should educate caregivers about the need to manage and reevaluate pain (statement 9).
* At least annually, clinicians who perform tonsillectomy should determine their rate of primary and secondary posttonsillectomy hemorrhage (statement 10).
Otolaryngol Head Neck Surg. Published online January 3, 2011.
Laurie Barclay, MD
January 3, 2011 — The prevalence of tonsillectomy, the associated morbidity, and the availability of hundreds of randomized clinical trials evaluating associated interventions create a pressing need for evidence-based guidance to aid clinicians, according to the multidisciplinary Clinical Practice Guideline: Tonsillectomy in Children, published online January 3, 2011, in Otolaryngology–Head and Neck Surgery.
"Over half a million tonsillectomies are done every year in the United States," said guideline coauthor Richard M. Rosenfeld, MD, MPH, from SUNY Downstate Medical Center and Long Island College Hospital in Brooklyn, New York, in a news release. "The tonsillectomy guideline will empower doctors and parents to make the best decisions, resulting in safer surgery and improved quality of life for children who suffer from large or infected tonsils."
The new guideline, which is intended for all clinicians in any setting who care for children 1 to 18 years old in whom tonsillectomy is being considered, offers evidence-based recommendations on identifying children who are the best candidates for tonsillectomy, and on preoperative, intraoperative, and postoperative care and management. Other objectives of this guideline include highlighting the need for evaluation and intervention in special populations, improving counseling and education for families, describing management options for patients with modifying factors, reducing inappropriate or unnecessary variations in care, and discussing the significant public health implications of tonsillectomy.
The definition of tonsillectomy is a surgical procedure in which the peritonsillar space between the tonsil capsule and the muscular wall is dissected to completely remove the tonsil, including its capsule. The term often refers to tonsillectomy with adenoidectomy, especially in relationship to sleep-disordered breathing (SDB) or other contexts where adenoidectomy is appropriate.
SDB refers to a continuum of obstructive disorders ranging in severity from primary snoring to obstructive sleep apnea (OSA). SDB is characterized by abnormalities of respiratory pattern or of the adequacy of ventilation during sleep, as well as by associated daytime symptoms such as excessive sleepiness, inattention, poor concentration, and hyperactivity.
Indications for tonsillectomy include recurrent throat infections and SDB, both of which can significantly impair childhood health and quality of life (QoL). Throat infection, which includes strep throat and acute tonsillitis, pharyngitis, adenotonsillitis, or tonsillopharyngitis, is defined as sore throat caused by viral or bacterial infection of the pharynx, palatine tonsils, or both, which may or may not be culture positive for group A streptococcus.
"The importance of tonsillectomy as an intervention relates to its documented benefit on child QoL," the guidelines authors write. "For example, when compared with healthy children, children with recurrent throat infections have more bodily pain and poorer general health and physical functioning. Tonsillectomy may improve QoL by reducing throat infections, health care provider visits, and the need for antibiotic therapy."
SDB in children is also associated with cognitive and behavioral impairment that usually improves after tonsillectomy, as do QoL, sleep disturbance, and vocal quality. The potential benefits of tonsillectomy must be weighed against possible surgical complications, including throat pain; postoperative nausea and vomiting; delayed feeding; voice changes; hemorrhage; and, rarely, death.
Guideline Recommendations
Specific recommendations included in the clinical practice guideline are as follows:
* Watchful waiting for recurrent throat infection is recommended if there have been fewer than 7 episodes in the previous year, fewer than 5 episodes per year in the previous 2 years, or fewer than 3 episodes per year in the previous 3 years (statement 1).
* Tonsillectomy may be an option for recurrent throat infection with a frequency of at least 7 episodes in the previous year, at least 5 episodes per year for 2 years, or at least 3 episodes per year for 3 years, provided that the medical record documents each episode of sore throat and the presence of at least one of the following: temperature of more than 38.3°C, cervical adenopathy, tonsillar exudate, or positive test result for group A β-hemolytic streptococcus (statement 2).
* Children with recurrent throat infection who do not meet the criteria in statement 2 may have modifying factors favoring tonsillectomy, including but not limited to multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyngitis and adenitis, or a history of peritonsillar abscess (statement 3).
* Clinicians should ask caregivers of children with SDB and tonsillar hypertrophy about comorbid conditions that might improve after tonsillectomy, such as growth retardation, poor school performance, enuresis, and behavioral problems (statement 4).
* Caregivers of children with abnormal polysomnography results who also have tonsillar hypertrophy and SDB should be counseled about tonsillectomy as a means to improve health issues related to SDB (statement 5).
* Caregivers should be informed that SDB may persist or recur after tonsillectomy and may require further management (statement 6).
* A single, intraoperative dose of intravenous dexamethasone should be given to children undergoing tonsillectomy (statement 7; strong recommendation).
* Clinicians should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillectomy (statement 8; strong recommendation).
* Clinicians should advocate for pain management after tonsillectomy and should educate caregivers about the need to manage and reevaluate pain (statement 9).
* At least annually, clinicians who perform tonsillectomy should determine their rate of primary and secondary posttonsillectomy hemorrhage (statement 10).
Otolaryngol Head Neck Surg. Published online January 3, 2011.
Wednesday, December 29, 2010
Sucrose Analgesia for Infants: State of the Science
From Medscape Pediatrics > Viewpoints
Analgesic Effects of Sweet-Tasting Solutions for Infants: Current State of Equipoise
Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B
Pediatrics. 2010;126:894-902
Study Summary
This article describes a meta-analysis of multiple randomized controlled trials that evaluated oral sucrose (or other sugar product) for acute, painful procedures in infants. Harrison and colleagues examined whether a state of equipoise (equilibrium about whether an intervention is likely to be helpful) still exists in regard to the use of oral sucrose for pain amelioration.
They noted that many randomized, placebo-controlled trials have been conducted despite the fact that reviews published throughout the 2000s demonstrated overwhelming evidence of clinical effectiveness. In addition to conducting a meta-analysis of the literature, this study sought to identify research questions or areas upon which future studies could focus.
The investigators reviewed 4 online literature databases and existing evidence-based reviews on the topic. They identified 125 primary research studies on the topic, with 49% using heel lance as the painful procedure, 14% using venipuncture or intramuscular injection, and 6% studying pain relief related to circumcision.
In 103 studies (93%), the use of sucrose or other sweet solution reduced pain response. One of 8 studies evaluating pain control with circumcision had negative results, but the other 7 (87.5%) demonstrated benefit. The solutions used in the trial varied greatly, but the most common was sucrose.
In general, sweeter solutions (higher concentrations) tended to have higher rates of success. The investigators concluded that there is no longer ethical justification for placebo groups in trials investigating the use of sweet solutions to limit short-term procedural pain. They pointed out the following knowledge gaps that could ethically be the focus of future investigation:
* Are sweet solutions effective in mitigating procedural pain for extremely premature infants?
* Are repeated administrations of the solution more effective than single administrations?
* Are sweet solutions effective over extended hospitalizations?
* How do sweet solutions compare with narcotic pain medications for short procedures?
* What is the effectiveness of sweet solutions for longer noxious procedures?
* Are sweet solutions effective in this setting for older children?
Harrison and coworkers suggested that these unanswered questions should be the focus of future research.
Analgesic Effects of Sweet-Tasting Solutions for Infants: Current State of Equipoise
Harrison D, Bueno M, Yamada J, Adams-Webber T, Stevens B
Pediatrics. 2010;126:894-902
Study Summary
This article describes a meta-analysis of multiple randomized controlled trials that evaluated oral sucrose (or other sugar product) for acute, painful procedures in infants. Harrison and colleagues examined whether a state of equipoise (equilibrium about whether an intervention is likely to be helpful) still exists in regard to the use of oral sucrose for pain amelioration.
They noted that many randomized, placebo-controlled trials have been conducted despite the fact that reviews published throughout the 2000s demonstrated overwhelming evidence of clinical effectiveness. In addition to conducting a meta-analysis of the literature, this study sought to identify research questions or areas upon which future studies could focus.
The investigators reviewed 4 online literature databases and existing evidence-based reviews on the topic. They identified 125 primary research studies on the topic, with 49% using heel lance as the painful procedure, 14% using venipuncture or intramuscular injection, and 6% studying pain relief related to circumcision.
In 103 studies (93%), the use of sucrose or other sweet solution reduced pain response. One of 8 studies evaluating pain control with circumcision had negative results, but the other 7 (87.5%) demonstrated benefit. The solutions used in the trial varied greatly, but the most common was sucrose.
In general, sweeter solutions (higher concentrations) tended to have higher rates of success. The investigators concluded that there is no longer ethical justification for placebo groups in trials investigating the use of sweet solutions to limit short-term procedural pain. They pointed out the following knowledge gaps that could ethically be the focus of future investigation:
* Are sweet solutions effective in mitigating procedural pain for extremely premature infants?
* Are repeated administrations of the solution more effective than single administrations?
* Are sweet solutions effective over extended hospitalizations?
* How do sweet solutions compare with narcotic pain medications for short procedures?
* What is the effectiveness of sweet solutions for longer noxious procedures?
* Are sweet solutions effective in this setting for older children?
Harrison and coworkers suggested that these unanswered questions should be the focus of future research.
Tuesday, December 28, 2010
Complementary, Alternative Medicine Linked to Adverse Events in Children
From Medscape Medical News
Laurie Barclay, MD
December 27, 2010 — The use of complementary and alternative medicine (CAM) can be associated with serious, and even fatal, adverse events in children, according to the results of a monthly active surveillance study reported online December 22 in the Archives of Disease in Childhood.
"...CAM is commonly administered to children," write Dr. Alissa Lim, from Royal Children's Hospital in Melbourne, Australia, and colleagues. "As CAM is frequently regarded as natural and therefore safe, adverse events may go unreported."
The goal of the study was to assess the types of adverse events linked to use of CAM that came to the attention of Australian pediatricians. Between January 2001 and December 2003, a total of 39 cases of adverse events associated with CAM use were reported to the Australian Paediatric Surveillance Unit, and a physician completed the questionnaire.
Almost two thirds of the reported cases (64%) were considered to be severe, life threatening, or fatal. Reported adverse events included constipation, bleeding, pain, allergic reactions, mouth ulcers, seizures, vomiting, stunted growth, infections, and malnutrition.
Several areas of concern were apparent that posed significant risks, including those related to failure to use conventional medicine because CAM therapy was substituted, those associated with medication changes made by CAM practitioners, and those caused by dietary restriction in the belief that this would cure symptoms. There were 4 reported deaths associated with a failure to use conventional medicine because a CAM treatment was substituted.
"CAM use has the potential to cause significant morbidity and fatal adverse outcomes," the study authors write. "The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored."
Limitations of this study include lack of information about the products used, information collected only from pediatricians, and underreporting by families and also by clinicians because of time pressures and uncertainly about causality and severity of outcome. Although 46 instances of adverse events associated with CAM were reported during the study period, only 40 questionnaires were completed, and one of these was a duplicate, leaving 39 cases for analysis.
"Discussions with families about CAM use may empower them to talk about any medication changes suggested by a CAM practitioner before altering or ceasing the medication," the study authors conclude. "However, many of the adverse events associated with failure to use conventional medicine resulted from the family's belief in CAM and determination to use it despite medical advice."
The study authors have disclosed no relevant financial relationships.
Arch Dis Child. Published online December 22, 2010. Abstract
Laurie Barclay, MD
December 27, 2010 — The use of complementary and alternative medicine (CAM) can be associated with serious, and even fatal, adverse events in children, according to the results of a monthly active surveillance study reported online December 22 in the Archives of Disease in Childhood.
"...CAM is commonly administered to children," write Dr. Alissa Lim, from Royal Children's Hospital in Melbourne, Australia, and colleagues. "As CAM is frequently regarded as natural and therefore safe, adverse events may go unreported."
The goal of the study was to assess the types of adverse events linked to use of CAM that came to the attention of Australian pediatricians. Between January 2001 and December 2003, a total of 39 cases of adverse events associated with CAM use were reported to the Australian Paediatric Surveillance Unit, and a physician completed the questionnaire.
Almost two thirds of the reported cases (64%) were considered to be severe, life threatening, or fatal. Reported adverse events included constipation, bleeding, pain, allergic reactions, mouth ulcers, seizures, vomiting, stunted growth, infections, and malnutrition.
Several areas of concern were apparent that posed significant risks, including those related to failure to use conventional medicine because CAM therapy was substituted, those associated with medication changes made by CAM practitioners, and those caused by dietary restriction in the belief that this would cure symptoms. There were 4 reported deaths associated with a failure to use conventional medicine because a CAM treatment was substituted.
"CAM use has the potential to cause significant morbidity and fatal adverse outcomes," the study authors write. "The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored."
Limitations of this study include lack of information about the products used, information collected only from pediatricians, and underreporting by families and also by clinicians because of time pressures and uncertainly about causality and severity of outcome. Although 46 instances of adverse events associated with CAM were reported during the study period, only 40 questionnaires were completed, and one of these was a duplicate, leaving 39 cases for analysis.
"Discussions with families about CAM use may empower them to talk about any medication changes suggested by a CAM practitioner before altering or ceasing the medication," the study authors conclude. "However, many of the adverse events associated with failure to use conventional medicine resulted from the family's belief in CAM and determination to use it despite medical advice."
The study authors have disclosed no relevant financial relationships.
Arch Dis Child. Published online December 22, 2010. Abstract
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