• headache;
  • migraine;
  • ibuprofen;
  • children

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 leqslant R: less-than-or-eq, slant 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% (Table 3).

Table 3. 
EndpointIbuprofen (N=45)Placebo (N=39)P-value
Cum. % responders, 2 hr (1° endpoint)76%53%0.006
2 pt. improvement in severity, 2 hr27 (62%)11 (28%)leqslant R: less-than-or-eq, slant0.004
Median pain score at 2 hr23<0.02
Headache recurrence (within 4-24 hr)8 (18%)14 (36%)leqslant R: less-than-or-eq, slant0.06
Need for rescue medication1 (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 (Table 4):

Table 4. 
Cum. % responders76%53%0.006
Headache recurrence513<0.005

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.