Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Naval Medical Center, Portsmouth
• Treatments: Diphenhydramine; Haloperidol; Haloperidol decanoate; Metoclopramide; Promethazine

Criteria

Inclusion Criteria:

Migraine Headache must contain the following:

• At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain

• At least one: Nausea or Vomiting, Photophobia or phonophobia

• Ages 18-50

Exclusion Criteria:

• Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine

• History of ischemic heart disease or signs or symptoms of ischemic heart disease

• History of stroke or transient ischemic attack (TIA)

• History of peripheral vascular disease

• History of uncontrolled hypertension with presenting diastolic blood pressure > 100

• Use of an ergotamine derivatives, triptan, or dopamine-blocking anti-emetic within the past 24 hrs

• Concurrent administration or within 2 weeks of discontinuing an MAO inhibitor

• Concurrent management of hemiplegic or basilar migraine or known neurologic disorder

• Severe hepatic impairment

• Pregnancy or breastfeeding

• History of cancer (except non-melanoma skin cancer)

• Previous involvement in the study

• Febrile to 100.5 or greater

• Any indication for further diagnostic evaluation of this headache such as a lumbar puncture or CT scan.

• Headache differs from their normal headache