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

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)
Interventions Each participant treated 1 migraine with intranasal sumatriptan (20 mg) or placebo. The second migraine was treated with the other medication.
Outcomes
  • Headache relief at 2 h

  • Pain free at 2 h

  • Headache recurrence

  • Use of rescue medication

  • Presence of nausea or vomiting within 4 h

  • Adverse events


Other reported outcomes:
  • Presense of photophobia or phonophobia within 4 h

  • Other time points (30, 60, 180, 240 minutes)

  • Time to meaningful recovery

  • Treatment preference

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