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. 2016 Apr 19;2016(4):CD005220. doi: 10.1002/14651858.CD005220.pub2

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)
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
  • Headache relief at 2 h (reduction of severe or moderate pain by at least 2 grades)

  • Pain‐free at 2 h

  • Use of rescue medications

  • Adverse events


Other reported outcomes:
  • Patient preference

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