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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea, Migraine Headaches, Restlessness

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Metoclopramide 10mg
* Drug: Diphenhydramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haloperidol and Diphenhydramine<br>Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1 | Drug: Haloperidol<br>* 5mg IV<br>* Other names: Haldol;Drug: Diphenhydramine<br>* 25mg IV<br>* Other names: Benadryl;|
| Active Comparator: Metoclopramide and Diphenhydramine<br>Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1 | Drug: Metoclopramide 10mg<br>* 10mg IV<br>* Other names: Reglan;Drug: Diphenhydramine<br>* 25mg IV<br>* Other names: Benadryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on the visual analog scale |  | 20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and restlessness scores on the visual analog scales |  | 20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later |