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 < or = 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.-R 1997) 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 degrees 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). 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): No AE's were reported.


CONCLUSIONS
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.
Lewis
Donald W
DW
Division of Pediatric Neurology, Norfolk, Va 23510, USA.
Kellstein
David
D
Dahl
Georg
G
Burke
Bonnie
B
Frank
L M
LM
Toor
S
S
Northam
R S
RS
White
L W
LW
Lawson
L
L
D000208:Acute Disease; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D004366:Nonprescription Drugs; D011446:Prospective Studies; D012737:Sex Factors; D013535:Suspensions; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D004366:Nonprescription Drugs; D013535:Suspensions; D007052:Ibuprofen