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Sumatriptan for migraine attacks in children: a randomized placebo-controlled study. Do children with migraine
M L Hämäläinen1, K Hoppu, P Santavuori
1Department of Pediatric Neurology, Children's Hospital, Helsinki, Finland.
Insights
Sumatriptan did not show statistically significant efficacy for pediatric migraine relief in this trial. However, children showed a clear preference for sumatriptan over placebo.
Area of Science:
- Neurology
- Pediatric Medicine
- Clinical Pharmacology
Background:
- Oral sumatriptan is a proven acute treatment for adult migraines.
- Pediatric migraine treatment efficacy for sumatriptan remains undetermined.
- Migraine significantly impacts children's quality of life.
Purpose of the Study:
- To evaluate the efficacy of oral sumatriptan in treating acute migraine in children.
- To compare sumatriptan's effectiveness against a placebo in a pediatric population.
- To assess children's preference for sumatriptan versus placebo.
Main Methods:
- Randomized, double-blind, placebo-controlled, crossover trial.
- Twenty-three children (aged 8.3–16.4 years) participated.
- Primary endpoint: ≥50% decrease in pain intensity at 2 hours on a visual analogue scale.
Main Results:
- No statistically significant difference in the primary endpoint between sumatriptan and placebo (7/23 vs. 5/23).
- Complete headache resolution rates were not significantly different (5/23 vs. 2/23).
- Children significantly preferred sumatriptan over placebo (13/23 vs. 2/23, p=0.004).
Conclusions:
- Oral sumatriptan did not demonstrate statistically significant efficacy for acute migraine in children in this study.
- The study suggests potential differences in sumatriptan response between children and adults.
- Patient preference favored sumatriptan, indicating a possible subjective benefit or other factors.
Abstract:
Oral sumatriptan is an effective acute treatment for migraine in adults, but its efficacy in children is still undetermined. Twenty-three children, aged 8.3 to 16.4 years, took both sumatriptan and placebo in a randomized, double-blind, placebo-controlled, crossover trial. The primary endpoint was a > or = 50% decrease in pain intensity on a 100-mm visual analogue scale at 2 hours. Other endpoints of efficacy were pain intensity difference (PID), showing pain relief at each time point; summed pain intensity differences (SPIDs), estimating overall pain relief; and preference. Two hours after sumatriptan, 7 of 23 reached the primary endpoint, and after placebo, 5 of 23 (difference 9%, 95% CI for difference, -21 to 38%; p = ns). Within 2 hours, the headache disappeared completely in 5 of 23 children after sumatriptan and in 2 of 23 children after placebo (p = ns). Median PIDs were slightly better for sumatriptan between 0.5 and 4 hours (p = ns). Median SPIDs increased almost identically up to 2 hours. Thereafter, median SPIDs for placebo remained practically constant, whereas for sumatriptan, the improvement continued. At 4 hours, the median SPID for sumatriptan was 2.4 times as high as for placebo. However, the maximum differences between median SPIDs at 4 hours (38.5, 95% CI, -75.8 to 57.5; Wilcoxon signed rank test, p = 0.4) or at any other point were not statistically significant. Of the 23 children, 13 preferred sumatriptan and 2 placebo (sign test, p = 0.004). The failure of this and previous controlled studies suggests that the response of children to sumatriptan may be different from adults.