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Sumitriptan for Migraine Headaches in Children Has Not Been Proven Efficacious

Question

  • In children with migraine headaches is oral sumitriptan effective in decreasing pain intensity?

Clinical Bottom Lines

  1. Some children do not benefit from NSAIDs used for treatment of migraine headaches. Sumitriptan has had proven efficacy in adults but this study failed to find convincing efficacy in the pediatric population even though most endpoints seemed to favor sumitriptan.
  2. Two hours after sumitriptan, 7 of 23 reached the primary endpoint and after placebo, 5 of 23 reached the endpoint (not statistically significant).
  3. Other endpoints of efficacy were assessed, but again did not demonstrate statistical significance when compared to placebo.


Summary of Key Evidence

  1. 23 children aged 8.3 to 16.4 years who suffered at least 2 migraine headaches/month and who had not benefited from previous medications were included in the study. They took both sumitriptan and placebo in a randomized double-blind, placebo controlled, cross-over trial.1
  2. The sumitriptan dose was 50 mg for BSA approx. 0.75-1.5 m2 (6-12 y/o) and 100 mg for BSA > 1.5 m2 (>12 y/o).
  3. Each child treated migraine headache attack with sumitriptan and one with placebo in random order.
  4. The study excluded children with other medical problems or those on chronic medications.
  5. The main efficacy variable was headache severity. The primary endpoint was a 50% or greater decrease in pain intensity on a 100 mm visual analog scale at 2 hours.
  6. Other endpoints of efficacy were 1) Pain Intensity Difference (pain intensity before minus pain intensity at assessment), essentially showing pain relief at each time point, 2) Summed Pain Intensity Differences, an estimate of overall pain relief during a time period, and 3) estimates of overall pain relief and preference.
  7. Two hours after sumitriptan, 7 of 23 reached the primary endpoint and after placebo 5 of 23, not statistically significant. There was no difference in gender, age, stage of pubertal development, or frequency of migraine headaches.
  8. Within 2 hours, the headache disappeared completely in 5 of 23 children with sumitriptan and in 2 of 23 children with placebo (not significant).
  9. Median Pain Intensity Differences were slightly better for sumitriptan between 0.5 and 4 hours (not significant).
  10. Median Summed Pain Intensity Differences (SPID) increased almost identically for up to 2 hours. Although median SPID’s for placebo remained constant, with sumitriptan they continued to improve. At 4 hours the median SPID for sumitriptan was 2.4 times as high as placebo, still not statistically significant.
  11. 13 of 23 children preferred sumitriptan. 2 of 23 preferred placebo. (p = 0.004).
  12. Adverse events reported included vomiting, photophobia, nausea and dizziness.

Additional Comments

  • The failure of this and previous controlled studies to demonstrate convincing efficacy for use of sumitriptan children may suggest that children respond differently than adults to this serotonin agonist.
  • However, the fact that children preferred sumitriptan over placebo suggests that they may be perceiving a difference in efficacy that the study did not detect.
  • The differential response in children in this study may be due to
    • study design where children included in the study had failed to respond to earlier treatments
    • pharmacokinetic or pharmacodynamic differences
    • hormone changes associated with puberty
  • The authors believe that adequate doses of ibuprofen can achieve similar to or better efficacy than sumitriptan.
  • More data is needed on the efficacy and safety of sumitriptan in the pediatric population.

Citation

  1. Hamalainen ML, Hoppu K and Santavuori P. Sumitriptan for migraine attacks in children: A randomized placebo-controlled study. Do children with migraine respond to oral sumitriptan differently from adults? Neurology. 48:1100-1103, 1997.

CAT Author: Amy Mikhail, MD

CAT Appraisers: John G. Frohna, MD

Date appraised: March 1, 1999

Last updated June 15, 2003
Department of Pediatrics and Communicable Diseases
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