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my personal edition > migraine > news
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DGReview
Ibuprofen Suspension Effective Treatment For Paediatric Migraine
A DGReview of :"Children's Ibuprofen Suspension for the Acute Treatment of Pediatric Migraine."
Headache
11/07/2002
By David Loshak
Paediatric ibuprofen suspension at an over-the-counter dose of 7.5 mg/kg relieves acute childhood migraines and is well tolerated.
Specialists in paediatric neurology in Norfolk, Virginia, United States, drew attention, however, to a "striking difference" in response rates between the sexes. Boys responded at a statistically significant rate, the specialists said and because of a very high placebo responder rate, the girls did not.
The specialists noted that migraine occurs in 4 percent of young children. There was little controlled clinical research in the treatment of childhood migraine and there were no approved drugs in the US for its treatment in children aged 12 years or younger.
To assess the efficacy and tolerability of a single over-the-counter children's ibuprofen suspension 7.5 mg/kg versus placebo for the acute treatment of one attack of migraine, the specialists conducted a prospective, double-blind, placebo-controlled, parallel group, randomised study of children aged 6-12 years.
There were two measures of efficacy. The first was headache severity based on a four point scale (severe, moderate, mild and no headache) at 30, 60, 90, 120, 180 and 240 minutes post-dose. The second was nausea, vomiting, photophobia and phonophobia at 120 minutes.
The primary endpoint of the study was the cumulative percentage of responders (severe or moderate headache reduced to mild or none) by 120 minutes.
Secondary endpoints were headache recurrence within 4 to 24 hours and any need for rescue medication within four hours.
Of 138 children enrolled in the study, 84 were treated and completed diaries. Of these, 45 received ibuprofen and 39 received placebo. The two groups were demographically, diagnostically and clinically comparable.
Nausea was eliminated in 60 percent of the children given ibuprofen compared with 39 percent of those given placebo - a statistically significant difference.
Vomiting, photophobia and phonophobia fell marginally but not significantly at two hours.
Headache 2002; 42(8):780-786.
"Children's Ibuprofen Suspension for the Acute Treatment of Pediatric Migraine."
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