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Updated: Aug 15, 2026

Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
Unlicensed and off label analgesic use in paediatric pain management
1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK.
Insights
This study found that 33% of analgesic prescriptions for children involved off-label drug use, highlighting a common issue in pediatric pain management. While no unlicensed medicines were used, off-label prescribing remains a significant concern.
Area of Science:
- Pediatric Pharmacology
- Pain Management
- Drug Utilization
Background:
- Pediatric pain management has advanced significantly.
- Use of unlicensed and off-label medications complicates pediatric pharmacotherapy.
- This study addresses practical issues arising from such drug use.
Purpose of the Study:
- To document the incidence of unlicensed and off-label analgesic agents in children.
- To analyze the nature of analgesic drug use in a pediatric population.
Main Methods:
- Prospective data collection of analgesic use over a 4-week period from two hospital wards.
- Analysis of prescription episodes to classify drug use as licensed, unlicensed, or off-label.
Main Results:
- A total of 715 prescription episodes were analyzed.
- 67% of prescriptions involved licensed medicines.
- 33% of prescriptions utilized licensed medicines in an off-label manner; no unlicensed medicines were identified.
Conclusions:
- The study highlights significant issues concerning off-label drug use in pediatric pain management.
- Paracetamol was the most frequently prescribed analgesic.
- Recommendations for future strategies to address off-label prescribing are discussed.
Background:
The management of pain in children has advanced enormously in recent years. Pharmacological treatment of pain is complicated however, by the widespread use of unlicensed and off label medicines in the paediatric population, leading to everyday practical problems. This study aimed to document the incidence and nature of unlicensed and off label analgesic agents in children.
Methods:
Data regarding analgesic use were collected prospectively over a 4-week period from two wards. The data were analysed to determine whether the drug use was licensed, unlicensed or off label.
Results:
Seven hundred and fifteen prescription episodes were analysed. Some 480 of these (67%) were licensed; 235 were licensed medicines used in an off label manner (33%). No medicines were unlicensed. Paracetamol was the most common analgesic used.
Conclusion:
Issues regarding the use of off label drugs in children at risk of pain are discussed. Suggestions are made regarding the way forward for the future.
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