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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098499
• Other study ID #: NMCP.2012.0008
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2014
• Last updated: March 27, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headaches
• Nausea
• Restlessness

Intervention

Drug:
• Haloperidol
5mg IV
• Metoclopramide 10mg
10mg IV
• Diphenhydramine
25mg IV

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QT prolongation caused by the administration of Haloperidol	EKGs were performed prior to the administration of study meds and then again at the completion of the study.	2 hours after administration of Haldol	Yes
Primary	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	No
Secondary	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	No