Ueberall 1999.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, 2‐way cross‐over trial of intranasal sumatriptan | |
Participants | Participants were < 10 years of age with migraine with or without aura per IHS 1988 criteria and at least 2 migraine attacks per month Randomized (N = 14); analyzed (N = 14) |
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Interventions | Each participant treated 1 migraine with intranasal sumatriptan (20 mg) or placebo. The second migraine was treated with the other medication. | |
Outcomes |
Other reported outcomes:
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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) | Low risk | Quote: "Randomization was based on a computer algorithm. . ." |
Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to two alternative treatment strata"; "access to treatment assignments were given to D.W., if necessary" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "0.9% sodium chloride" used as placebo Comment: cross‐over trial; blinding likely maintained. Disturbance of taste reported both for sumatriptan and placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Data sufficient for analysis were provided by all 14 children". |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |