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Additive Value of Intranasal Fentanyl on Ibuprofen for Pain Management of Children With Moderate to Severe Headaches:
Ariane Boutin1, Serge Gouin1, Benoit Bailey1
1Department of Pediatric Emergency Medicine, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada.
Insights
Intranasal fentanyl did not provide additional pain relief for children with headaches in the emergency department. This study found no significant benefit compared to placebo when used with ibuprofen.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Clinical Pharmacology
Background:
- Limited research exists on rapid pain relief medications for pediatric headaches in emergency settings.
- Headaches are a common reason for pediatric emergency department visits.
Purpose of the Study:
- To evaluate the efficacy of intranasal fentanyl (INF) for pain reduction in children with moderate to severe headaches.
- To compare INF plus ibuprofen against placebo plus ibuprofen in a pediatric emergency department.
Main Methods:
- A single-center, double-blinded, randomized, placebo-controlled trial.
- Inclusion criteria: children aged 8-17 years with moderate to severe headaches.
- Intervention: intranasal fentanyl (1.5 µg/kg) or placebo, co-administered with oral ibuprofen (10 mg/kg).
Main Results:
- No significant difference in mean pain reduction at 15 minutes between INF and placebo groups (mean difference 2 mm).
- Similar pain reduction observed at 30 and 60 minutes.
- More frequent, but minor and transient, adverse events in the intranasal fentanyl group.
Conclusions:
- Intranasal fentanyl did not demonstrate additional benefit for pain relief in pediatric headaches.
- Further research may be needed to explore alternative rapid-acting analgesics for pediatric emergency care.
Background:
Few studies have evaluated the rapid pain improvement provided by medications for children presenting to an emergency department (ED) with headaches.
Objective:
Our aim was to evaluate pain reduction provided by intranasal fentanyl (INF) compared with placebo in addition to ibuprofen.
Methods:
A single-center, double-blinded, randomized, placebo-controlled clinical trial was conducted in a tertiary care pediatric ED. All children aged 8-17 years presenting with a moderate to severe headache were eligible. Study participants were randomly allocated to receive INF 1.5 µg/kg (maximum dose of 100 µg) or similar placebo solution. Co-administration of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) was also provided. The primary outcome was the mean pain rating reduction at 15 min.
Results:
Among the 62 participants, the median age was 14 years (interquartile range [IQR] 12-16 years in both groups) and the median initial visual analog scale (VAS) score was 64 (IQR 55-72 in the intervention group; IQR 50-81 in the control group). There was no difference in the mean pain score reduction at 15 min between the two groups (mean difference 2 mm; 95% CI -7 to 11 mm). Mean VAS score reductions were also similar at 30 and 60 min. Adverse events were more frequent in the INF group (risk ratio 2.8; 95% CI 1.29 to 6.22), but all events were minor and transient. No significant differences were found in other outcomes.
Conclusions:
This study did not find a benefit from INF for providing additional pain relief in children presenting to ED with headaches.
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