Hämäläinen 1997c.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, 4‐way cross‐over trial of oral dihydroergotamine | |
Participants | Children or adolescents < 18 years with a diagnosis of migraine per IHS 1988 criteria and at least 2 migraine attacks per month. Most participants had participated in a previous trial of paracetamol and ibuprofen versus placebo. Randomized (N = 16); 1 medication used (N = 13); analyzed (N = 12) |
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Interventions | Dihydroergotamine (DHE) mesylate oral solution 2 mg/ml and placebo. Each participant treated 1 migraine attack at home with DHE 20 µg/kg (DHE solution 2 drops/10 kg) and 1 with placebo. If the first dose provided any relief, a second dose could be taken after 1 h. If neither treatment produced an adequate response, 1 further migraine attack was treated with DHE 40 µg/kg and 1 with placebo after contact with the investigator. | |
Outcomes |
Other reported outcomes:
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Headache severity scale | 5‐point scale (5 severe, 3‐4 moderate, 2 mild, 1 no pain) | |
Funding source | Not specified | |
Publication | Journal | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "each patient received two identical bottles" Comment: the taste may have been different between the bottles |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: patients who were excluded were not described |
Selective reporting (reporting bias) | Low risk | Comment: all expected outcomes reported |