Children's Ibuprofen Suspension for the Acute Treatment of Pediatric Migraine

Objective.—To compare the efficacy of a single over‐the‐counter dose (7.5 mg/kg, p.o.) of children's ibuprofen suspension vs. placebo for the acute treatment of pediatric migraine. Background.—Migraine occurs in 4% of young children. There is a paucity of controlled clinical research in the treatment of childhood migraine and there are currently no approved drugs in the USA for treatment of migraine in children 12 years of age. The purpose of this study is to assess the efficacy and tolerability of a single OTC dose of ibuprofen suspension for the acute treatment of childhood migraine. Methods.—Prospective, double‐blind, placebo‐controlled, parallel group, randomized study of children 6‐12 yrs with migraine (I.H.S.‐R1997) treating 1 attack with a 7.5 mg/kg liq. ibuprofen vs matching placebo. Efficacy measures: (1) Headache severity based upon a 4 pt scale (severe, mod., mild, no headache) at 30, 60, 90, 120, 180 and 240 minutes post dose, and (2) nausea, vomiting, and photo/phonophobia at 120 min. The 1° endpoint was cumulative % of responders (severe or mod. headache reduced to mild or none) by 120 minutes. Secondary endpoints were headache recurrence within 4‐24 hours and need for rescue medicines within 4 hours. Results.—138 enrolled; 84 treated/completed diary. 45 active agent, 39 placebo. The 2 groups were comparable (active: placebo) ‐ Ages: 9: 9.1, gender boy/girl ‐ 1.25: 1.6, and diagnosis: migraine w/o aura ‐ 86%: 79%. Concomitant use of prophylactic Rx: 24%: 10% . Endpoint Ibuprofen (N=45) Placebo (N=39) P ‐value Cum. % responders, 2 hr (1° endpoint) 76% 53% 0.006 2 pt. improvement in severity, 2 hr 27 (62%) 11 (28%) 0.004 Median pain score at 2 hr 2 3 <0.02 Headache recurrence (within 4‐24 hr) 8 (18%) 14 (36%) 0.06 Need for rescue medication 1 (2%) 15 (38%) <0.001 Nausea was eliminated in 60% of the ibuprofen treated patients and 39% of the placebo group (p<0.001). Vomiting, photophobia and phonophobia had marginal, but not statistically significant, decreases at 2 hours. A striking gender difference was noted : Endpoint Ibuprofen Placebo P ‐value Cum. % responders 76% 53% 0.006 BOYS 84% 43.4 <0.0006 GIRLS 65% 66.7 0.8 Headache recurrence 5 13 <0.005 BOYS 0 8 <0.001 GIRLS 5 5 NS No AE's were reported. Conclusion.—Children's ibuprofen suspension at an OTC dose of 7.5 mg/kg is an effective and well‐tolerated agent for pain relief in the acute treatment of childhood migraine, particularly in boys. There is a striking difference in gender response rates and placebo responder rates between girls and boys. The boys responded at a statistically significant rate, and girls failed to do so because of a very high placebo responder rate. Multi‐center trials are recommended.