Clinical trial NCT02098499: Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Official title: Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Headaches
Nausea
Restlessness
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2014-03-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.

Eligibility 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

Primary outcomes:
measure: Pain scores on the visual analog scale
timeFrame: 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
Secondary outcomes:
measure: Nausea and restlessness scores on the visual analog scales
timeFrame: 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later
Other outcomes:
measure: QT prolongation caused by the administration of Haloperidol
timeFrame: 2 hours after administration of Haldol
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, Portsmouth
name: Matthew Gaffigan, MD
role: PRINCIPAL_INVESTIGATOR
References: