A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis

Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7.

Abstract

Objective: We conducted a randomized trial among emergency department patients with migraine to determine the relative impact on migraine-associated symptoms of hydromorphone, an opioid, versus prochlorperazine, an antidopaminergic antiemetic.

Methods: This was a post hoc analysis of data from a double-blind study registered at http://clinicaltrials.gov (NCT02389829). Patients who met International Classification of Headache Disorders, 3rd edition criteria for migraine without aura or for probable migraine without aura were eligible for participation. Participants received either hydromorphone 1 mg IV or prochlorperazine 10 mg IV plus diphenhydramine 25 mg IV and could receive a second dose of the same medication 1 h later if needed. The outcomes were sustained relief of nausea, photophobia, and phonophobia.

Results: A total of 127 patients were enrolled, of whom 63 received prochlorperazine and 64 received hydromorphone. Of 49 patients in the prochlorperazine arm who reported nausea at baseline, 34 (69.4%) reported complete resolution without relapse versus 15/49 (30.6%) in the hydromorphone arm (absolute risk reduction [ARR] = 38.8%, 95% CI: 20.5%-57.0%, p < 0.001). Of 55 patients in the prochlorperazine arm who reported photophobia at baseline, 23 (41.8%) reported complete resolution without relapse versus 13/62 (20.9%) patients treated with hydromorphone (ARR = 20.8%, 95% CI: 4.3%-37.3%, p = 0.014). Of 56 patients in the prochlorperazine arm who reported phonophobia at baseline, 25 (44.6%) reported complete resolution without relapse versus 16/59 (27.1%) in the hydromorphone arm (ARR = 17.5%, 95% CI: 0.3%-34.8%, p = 0.049). For adverse events, three patients in the prochlorperazine arm reported anxiety or restlessness, and nine patients in the hydromorphone arm reported dizziness or weakness.

Conclusions: Prochlorperazine plus diphenhydramine is more efficacious than hydromorphone for the treatment of migraine-associated symptoms.

Keywords: hydromorphone; migraine; opioid; prochlorperazine; relief; sustained.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravenous
  • Adult
  • Analgesics, Opioid / administration & dosage
  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / pharmacology*
  • Antiemetics / administration & dosage
  • Antiemetics / adverse effects
  • Antiemetics / pharmacology*
  • Diphenhydramine / administration & dosage
  • Diphenhydramine / adverse effects
  • Diphenhydramine / pharmacology*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydromorphone / administration & dosage
  • Hydromorphone / adverse effects
  • Hydromorphone / pharmacology*
  • Hyperacusis / drug therapy*
  • Hyperacusis / etiology
  • Male
  • Middle Aged
  • Migraine Disorders / complications
  • Migraine Disorders / drug therapy*
  • Nausea / drug therapy*
  • Nausea / etiology
  • Outcome Assessment, Health Care
  • Photophobia / drug therapy*
  • Photophobia / etiology
  • Prochlorperazine / administration & dosage
  • Prochlorperazine / adverse effects
  • Prochlorperazine / pharmacology*

Substances

  • Analgesics, Opioid
  • Antiemetics
  • Diphenhydramine
  • Hydromorphone
  • Prochlorperazine

Associated data

  • ClinicalTrials.gov/NCT02389829