SUMATRIPTAN FOR MIGRAINE ATTACKS IN CHILDREN - A RANDOMIZED PLACEBO-CONTROLLED STUDY - DO CHILDREN WITH MIGRAINE RESPOND TO ORAL SUMATRIPTAN DIFFERENTLY FROM ADULTS

Citation
Ml. Hamalainen et al., SUMATRIPTAN FOR MIGRAINE ATTACKS IN CHILDREN - A RANDOMIZED PLACEBO-CONTROLLED STUDY - DO CHILDREN WITH MIGRAINE RESPOND TO ORAL SUMATRIPTAN DIFFERENTLY FROM ADULTS, Neurology, 48(4), 1997, pp. 1100-1103
Citations number
16
Categorie Soggetti
Clinical Neurology
Journal title
ISSN journal
00283878
Volume
48
Issue
4
Year of publication
1997
Pages
1100 - 1103
Database
ISI
SICI code
0028-3878(1997)48:4<1100:SFMAIC>2.0.ZU;2-I
Abstract
Oral sumatriptan is an effective acute treatment for migraine in adult s, but its efficacy in children is still undetermined. Twenty-three ch ildren, aged 8.3 to 16.4 years, took both sumatriptan and placebo in a randomized, double-blind, placebo-controlled, crossover trial. The pr imary endpoint was a greater than or equal to 50% decrease in pain int ensity on a 100-mm visual analogue scale at 2 hours. Other endpoints o f efficacy were pain intensity difference (PID), showing pain relief a t each time point; summed pain intensity differences (SPIDs), estimati ng overall pain relief; and preference. Two hours after sumatriptan, 7 of 23 reached the primary endpoint, and after placebo, 5 of 23 (diffe rence 9%, 95% CI for difference, -21 to 38%; p = ns). Within 2 hours, the headache disappeared completely in 5 of 23 children after sumatrip tan and in 2 of 23 children after placebo (p = ns). Median PIDs were s lightly better for sumatriptan between 0.5 and 4 hours (p = ns). Media n SPIDs increased almost identically up to 2 hours. Thereafter, median SPIDs for placebo remained practically constant, whereas for sumatrip tan, the improvement continued. At 4 hours, the median SPID for sumatr iptan was 2.4 times as high as for placebo. However, the maximum diffe rences between median SPIDs at 4 hours (38.5, 95% CI, -75.8 to 57.5; W ilcoxon signed rank test, p = 0.4) or at any other point were not stat istically significant. Of the 23 children, 13 preferred sumatriptan an d 2 placebo (sign test, p = 0.004). The failure of this and previous c ontrolled studies suggests that the response of children to sumatripta n may be different from adults.