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

Rothner 1999b.

Study characteristics
Methods Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral sumatriptan
Participants Participants from Canada (14 sites) were aged 12‐17 years, had a 3‐month history of migraine with or without aura as per the IHS 1988 criteria (except headaches could be < 2 h) and the migraine attack had lasted < 24 h.
Randomized (N = 119); withdrawn (N = 27); intention‐to‐treat and primary efficacy analysis (N = 92)
Interventions Each participant treated 1 migraine with oral sumatriptan (50 mg for body weight 30‐50kg; 100 mg for body weight > 50kg) or placebo. Use of rescue medication was permitted after 4 h of study treatment.
Outcomes
  • Headache relief at 2 h (2‐grade decrease in headache disability)

  • Pain free at 2 h

  • Presence of nausea

  • Use of rescue medication after 4 h

  • Headache recurrence within 24 h

  • Adverse events


Other reported outcomes:
  • 4 h time point

  • Presense of photophobia or phonophobia

  • Clinical disability

  • Time to start of headache improvement

  • Time to return to normal activities

  • Time until completely back to normal

Headache severity scale 4‐point scale (none, mild, moderate, severe)
Funding source GlaxoSmithKline
Publication Abstract and clinical trial registry
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Subjects were randomized (1:1:1 ratio) to receive. . ."
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding (performance bias and detection bias)
All outcomes Unclear risk Comment: described as "placebo‐controlled"; participant‐reported outcomes
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