Sumatriptan for migraine attacks in children: a randomized placebo-controlled study. Do children with migraine respond to oral sumatriptan differently from adults?

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.

RCT Entities:   Population Interventions Outcomes