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Trends of Opioids and Nefopam Use Among French Children: A Population-Based Study From 2009 to 2023
Sandrella Hamdan1,2,3, Pierre Pinson1, Jean-Marc Tréluyer1,4,5,6
1UMRS 1343 INSERM, Perinatal and Pediatric Pharmacology and Therapeutic Assessment, Université Paris Cité, Paris, France.
Insights
Opioid and nefopam use in French children increased, with tramadol and codeine being most common. Off-label prescribing, particularly tramadol in young children, rose, highlighting safety concerns.
Area of Science:
- Pediatric pharmacology
- Public health
- Drug utilization studies
Background:
- Effective pain management in children is crucial, but opioid risks are a significant concern.
- Understanding trends in pediatric analgesic prescribing is vital for patient safety.
Purpose of the Study:
- To describe trends in the use of opioids and nefopam among children in France from 2009 to 2023.
- To identify patterns of off-label prescribing and age-related use.
Main Methods:
- Nationwide drug utilization study using the French National Health Data System (SNDS).
- Inclusion of all children with prescriptions for weak opioids, strong opioids, or nefopam (2009-2023).
- Analysis of annual prevalence and temporal trends using joinpoint regression, stratified by age group.
Main Results:
- Overall analgesic use increased from 22.7‰ to 27.4‰, mainly due to weak opioids like tramadol and codeine.
- Nefopam use increased significantly, despite contraindications in children under 15.
- Tramadol use saw an eightfold increase in children aged 2-6 years, with frequent off-label prescribing for multiple analgesics.
Conclusions:
- Tramadol is the most prescribed opioid in French pediatric outpatients, with increasing off-label use, especially in younger children.
- The rise in tramadol and nefopam use, alongside increasing strong opioid prescriptions, necessitates enhanced surveillance.
- Urgent need for pediatric-specific safety data and stricter monitoring of analgesic prescribing in children.
Background And Objectives:
Effective pain management in children is a public health priority, while opioid-related risks remain a major concern. The aim of the present study was to describe trends of opioids and nefopam use in children in France.
Methods:
We conducted a nationwide drug utilization study using the French National Health Data System (SNDS), covering > 98% of the French population. All children with at least one prescription for a weak opioid, strong opioid, or nefopam between 2009 and 2023 were included. Annual prevalence of use was estimated per 1000 children, stratified by age group (< 2, 2-6, 7-11, 12-17 years). Joinpoint regression was used to analyze temporal trends. Contraindicated use was defined according to age restrictions in marketing authorizations.
Results:
Overall, 4,443,648 children were included in the study. Overall prevalence of analgesic use increased from 22.7‰ in 2009 to 27.4‰ in 2023, mainly driven by weak opioids (26.3‰ in 2023). In 2023, tramadol was the most prescribed weak opioid (13.5‰), followed by codeine (10.1‰). Nefopam use, contraindicated for use under 15 years of age, rose sharply to 1.9‰. Strong opioids, notably morphine and oxycodone, steadily increased but remained low (0.4‰ and 0.08‰, respectively). Most children receiving prescriptions were aged 12-17 years, although weak opioid use declined in this group over the study period. In contrast, children aged 2-6 years showed a fivefold increase in overall analgesic use, driven almost entirely by tramadol, which increased eightfold, while codeine use declined. Contraindicated use remained frequent for tramadol, codeine, opium powder, and nefopam, increasing as children approached the minimal approved age.
Conclusion:
Tramadol was the most commonly prescribed opioid used in pediatric outpatients in France in 2023, followed by codeine. Tramadol off-label use steadily increased, whereas codeine off-label use decreased. The sharp rise in tramadol, especially in children aged 2-6 years, and nefopam prescribing, together with increasing morphine and oxycodone use, in association with frequent contraindicated use, underscores the need for enhanced surveillance and pediatric-specific safety data.
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