Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac

Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.


Study objective: We compare the effectiveness of intravenous ketorolac and intravenous prochlorperazine in the treatment of pediatric migraine headaches.

Methods: We performed a prospective, randomized, double-blind clinical trial in 2 pediatric emergency departments (EDs) within children's hospitals. Children aged 5 to 18 years presenting to the ED with migraine headaches were eligible for the study. Contraindications to either medication or the inability to complete the pain score resulted in exclusion. Children were randomized to receive intravenous ketorolac (0.5 mg/kg; maximum 30 mg) or intravenous prochlorperazine (0.15 mg/kg; maximum 10 mg). All children also received a normal saline solution bolus. Successful treatment was defined as a 50% or greater reduction in the Nine Faces Pain Scale score at 60 minutes. If a less than 50% improvement occurred by 60 minutes, the child received the other medication. Forty-eight-hour follow-up telephone calls were made to each family to assess recurrence and late side effects.

Results: Sixty-two children were enrolled: 33 initially received prochlorperazine, and 29 initially received ketorolac. By 60 minutes, 16 (55.2%) of 29 of those who received ketorolac and 28 (84.8%) of 33 of those who received prochlorperazine were successfully treated (difference=30%; 95% confidence interval [CI] 8% to 52%). Fifty-six (93.3%) of the 60 children who completed the study were successfully treated by the study's conclusion. Approximately 30% of each group had a recurrence of some headache symptoms. Only 2 children reported side effects, both mild and self-limited.

Conclusion: In children, intravenous prochlorperazine is superior to intravenous ketorolac in the acute treatment of migraine headaches.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antiemetics / adverse effects
  • Antiemetics / therapeutic use
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Ketorolac / adverse effects
  • Ketorolac / therapeutic use*
  • Male
  • Migraine Disorders / drug therapy*
  • Pain / drug therapy
  • Pain Measurement
  • Prochlorperazine / adverse effects
  • Prochlorperazine / therapeutic use*
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Antiemetics
  • Prochlorperazine
  • Ketorolac