A Phase 3 interventional study of Tylenol in Obesity, Childhood, sponsored by Children's National Research Institute. Suspended at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Children's National Research Institute · Phase 3, Interventional, and Treatment
Although there are numerous studies investigating the pharmacokinetic properties of intravenous acetaminophen in infants and children with normal weight, there are none in the obese pediatric patient . This study will investigate the pharmacokinetics and pharmacodynamics of acetaminophen (total Cl and Vd) in obese children and adolescents
Obesity represents one of the most important public health issues according to the World Health Organization. It has reached epidemic proportions globally, with approximately 1.5 billion overweight adults aged 20 years and older and at least 600 million of them clinically obese .Childhood obesity is particularly problematic, because the co morbid disease states which accompany early obesity may require frequent pharmacotherapy and/or surgical intervention. Many of the metabolic and cardiovascular complications of obesity may also be present during childhood. Despite increased pharmacotherapy among obese patients, there is a paucity of dosing guidelines for this population. Optimal drug dosing in obese pediatric patients has not been explored as the present data available is specific for obese adults. Acetaminophen is one of the most commonly used medications in pediatric patients.
Although there are numerous studies investigating the pharmacokinetic properties of intravenous acetaminophen in infants and children with normal weight there are none in the obese pediatric patient . This study will investigate the pharmacokinetics and pharmacodynamics of acetaminophen (total clearance and volume of distribution in obese children and adolescents
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 6 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Children's National Research Institute is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosing of Tylenol for postoperative pain relief will include: children \< 16 years; 650 mg every 6 hours, max 2.6 gram per 24 hours and children \> or equal to 16 years every 6 hours 1 g of acetaminophen, max 4 gram per 24 hours).
Drug: Tylenol
Dosing of Tylenol for post operative pain control
Systemic clearance of acetaminophen and its metabolites (glucuronide, sulphate, cystein and mercapturic acid) in adolescent surgical patients
Time frame: up to 3 years
Evaluate postoperative pain management using the numerical rating scale system.
Time frame: up to 3 years
Plan to share: No
This study is suspended, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Children's National Research Institute