Clinical drug investigation · 2025
Trends of Opioids and Nefopam Use Among French Children: A Population-Based Study From 2009 to 2023.
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Hamdan Sandrella, Pinson Pierre, Tréluyer Jean-Marc, Kaguelidou Florentia, Chouchana Laurent, Smail-Faugeron Violaine
Аннотация
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.
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.