Lewis 2002.

Study characteristics
Methods	Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral ibuprofen
Participants	Participants were 6‐12 years of age and met diagnostic criteria for migraine without aura per revised IHS 1988 criteria for children (Winner 1995) from multiple sites in the United States. Enrolled (N = 138); treated/completed diary (N = 84)
Interventions	Each participant treated 1 migraine with liquid ibuprofen suspension (7.5 mg/kg) or placebo
Outcomes	Headache relief (defined as a reduction from moderate or severe to mild or no headache) at 2 h Pain‐free at 2 h Presence of nausea or vomiting at 2 h Headache recurrence from 4 to 24 h Use of rescue medication within 4 h Adverse events Other reported outcomes: Presence of photophobia or phonophobia at 2 h Time to response with other time points (30, 60, 90, 180, and 240 min)
Headache severity scale	4‐point scale (none, mild, moderate, severe)
Funding source	Not specified
Publication	Journal
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Subjects were randomly assigned (stratified by gender) to the study medication in a double‐blind fashion."
Allocation concealment (selection bias)	Unclear risk	Quote: "Subjects were randomized to one of the following groups in a 1:1 ratio"
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "matching placebo suspension" Comment: no description of taste or color
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Fifty‐four patients were randomized but were not evaluable. . . Six treated with study agent" Comment: missing outcome data balanced between intervention groups
Selective reporting (reporting bias)	Low risk	Comment: all expected outcomes were reported