Skip to main content
. 2016 Apr 19;2016(4):CD005220. doi: 10.1002/14651858.CD005220.pub2

Evers 2006.

Study characteristics
Methods Double‐blind, placebo‐controlled, cross‐over study to investigate the efficacy of oral zolmitriptan in the treatment of migraine attacks in children and adolescents
Participants Children and adolescents aged 6‐18 years from an headache outpatient clinic (not reported separately)
Migraine with and without aura according to the criteria of the ICHD‐2
No neurologic, psychiatric, and vascular disorder
Randomized (N = 32); withdrawn (N = 3); intention‐to‐treat and primary efficacy analysis (N = 29)
Interventions Ibuprofen 200 mg PO (children under 12) or 400 mg PO (adolescents)
Zolmitriptan 2.5 mg PO
Outcomes
  • Pain relief (defined as no or mild headache after moderate or severe headache) after 2 h

  • Pain free after 2 h

  • Headache recurrence and use of rescue medication within 24 h

  • Nausea and vomiting after 2 h

  • All adverse events classified (probably/possibly drug related or not drug related)


Other reported outcomes:
  • Pain‐free and headache relief after 0.5, 1, 4, and 24 h

  • Headache recurrence, sustained pain‐free response, frequency of accompanying symptoms (nausea, vomiting, photophobia, phonophobia) after 0.5, 1, 3, and 24 h

Headache severity scale 4‐point scale (none, mild, moderate, severe)
Funding source Not clear
Publication Journal
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The order of the study drugs was randomized for every patient."
Allocation concealment (selection bias) Low risk Comment: cross‐over study where each participant received the study drugs in random order
Blinding (performance bias and detection bias)
All outcomes Unclear risk Comment: blinding was not reported
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: 3 of 32 participants dropped out (withdrawal of consent N = 2) lost to follow‐up N = 1)
Selective reporting (reporting bias) Low risk Comment: aAll primary and secondary outcomes were reported