Related Experiment Video
Updated: Nov 4, 2025

Author Spotlight: A Multi-Depth Porcine Model for Comprehensive Study of Burn Injuries and Healing Processes
Published on: February 23, 2024
"Off-Label" Medicine Use In Burned Children: Three-Year Retrospective Study
I D Saputro1, O N Putra2, Hardiyono2
1Faculty of Medicine, Airlangga University-General Hospital of Dr. Soetomo, Surabaya, Indonesia.
Insights
Off-label prescribing is common in burned children, with 35% of medications used inappropriately for age, indication, or dosage. Analgesics were most frequently prescribed off-label, highlighting a need for further research in pediatric burn care.
Area of Science:
- Pediatric Burn Care
- Pharmacology
- Drug Utilization
Background:
- Pediatric burn patients present unique physiological challenges impacting drug response.
- Children are more likely to receive off-label prescriptions compared to adults due to altered pharmacokinetics.
Purpose of the Study:
- To determine the incidence of off-label prescribing in hospitalized burned children.
- To identify the types and reasons for off-label medication use in this population.
Main Methods:
- Retrospective observational study analyzing medical records of burned children (under 18) from January 2017 to December 2019.
- Inclusion criteria: hospitalized burn patients receiving at least one medication.
- Data collection focused on prescribed medications and classification of off-label use.
Main Results:
- 35% of 215 prescribed medications were off-label.
- Off-label use for age range was most common (53%), followed by indication (30%), dosage (15%), and dosage form (2%).
- Off-label prescribing was more prevalent in children aged 2-12 years compared to adolescents. Analgesics were the most common off-label therapeutic class.
Conclusions:
- A significant proportion of medications administered to burned children are prescribed off-label, often with uncertain evidence.
- Further research is crucial to address the safety and efficacy of off-label medications, particularly high-risk drugs, in pediatric burn patients.
Abstract:
Burn patients, especially children, experience many problems during their hospitalization. Because of their unique physiologic and altered pharmacokinetic profile, children receive more off-label prescribing than adults. The aim of this study was to analyze the incidence of off-label prescribing in burned children. This was a retrospective observational study conducted in the Dr. Soetomo General Hospital from December 2019 to March 2020. Data were collected from the medical records of burned children hospitalized over a 3-year period, from January 2017 to December 2019. Burn patients under 18 years old who received at least one prescribing medication were enrolled in this study. Twenty-six burned children met the inclusion criteria. A total of 215 medications were prescribed during this study and 35% of them were classified as off-label. The term off-label for age range was the highest among the off-label prescribing medicines, as much as 53%, with 30% classified for an unapproved indication, 15% for an unapproved dosage, and 2% for an unapproved dosage form. The prevalence of off-label prescribing was higher in children from 2 to 12 years old than in adolescents. Analgesics were the therapeutic classes most often prescribed as off-label in burned children. Most burned children are administered off-label medication with uncertain evidence. Further research is needed in this population to focus on several medications with high risk potential.
Related Concept Videos
Burn Injuries
The damage results in the death of skin cells, which can lead to a massive loss of fluid. Dehydration, electrolyte imbalance, and renal and circulatory failure follow, which can be fatal. Burn patients are treated with intravenous fluids to offset...
Drug Dosing: Infants and Children
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmacokinetics in Pediatric Patients: Drug Distribution
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

