Hämäläinen 2002.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, single attack cross‐over trial of sumatriptan nasal spray | |
Participants | Participants from 1 center in Germany were children 8‐12 years of age with 6‐month history of migraine with or without aura per IHS 1988 criteria, an attack frequency of 2‐8 monthly, and minimum duration of 4 h. Randomized (N = 60); withdrawn (N = 3); intention‐to‐treat analysis and primary efficacy analysis (N = 59) |
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Interventions | Each participant treated 1 migraine attack with nasal sumatriptan (10 mg) or placebo nasal spray. 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 | GlaxoSmithKline | |
Publication | Clinical trial registry | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized at visit one". Comment: probably done as with previous studies by sponsor but not reported |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomized at visit one and received a single dose of sumatriptan 10 mg nasal spray or placebo to treat one migraine attack. At visit 2 they received the alternate treatment. . ." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing outcome data balanced across intervention groups |
Selective reporting (reporting bias) | Low risk | Comment: all expected outcomes reported |