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

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Randomized (N = 60); withdrawn (N = 3); intention‐to‐treat analysis and primary efficacy analysis (N = 59)
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
  • Headache relief at 2 h (2‐point decrease in headache intensity)

  • Pain free at 2 h

  • Presence of nausea and vomiting at 2h

  • Use of rescue medication with 24 h

  • Adverse events


Other reported outcomes:
  • Headache relief, pain free, nausea, vomiting, photophobia, and phonophobia at 15, 30, 60, 90, 180, and 240 minutes

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