Back to resultsHaldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Primary Purpose
Migraine Headaches, Nausea, Restlessness
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Haloperidol
Metoclopramide 10mg
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headaches
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
Sites / Locations
- Naval Medical Center Portsmouth
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Haloperidol and Diphenhydramine
Metoclopramide and Diphenhydramine
Arm Description
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
Outcomes
Primary Outcome Measures
Pain scores on the visual analog scale
Secondary Outcome Measures
Nausea and restlessness scores on the visual analog scales
Full Information
NCT ID
NCT02098499
First Posted
March 17, 2014
Last Updated
March 27, 2014
Sponsor
United States Naval Medical Center, Portsmouth
1. Study Identification
Unique Protocol Identification Number
NCT02098499
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, Portsmouth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headaches, Nausea, Restlessness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Haloperidol and Diphenhydramine
Arm Type
Active Comparator
Arm Description
Haloperidol 5mg IV X1 and Diphenhydramine 25mg IV X1
Arm Title
Metoclopramide and Diphenhydramine
Arm Type
Active Comparator
Arm Description
Metoclopramide 10mg IV X1 and Diphenhydramine 25mg IV X1
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
5mg IV
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Other Intervention Name(s)
Reglan
Intervention Description
10mg IV
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
25mg IV
Primary Outcome Measure Information:
Title
Pain scores on the visual analog scale
Time Frame
20, 40, 60, and 80 min after administration of medications, and then again at the 48-72 hour mark
Secondary Outcome Measure Information:
Title
Nausea and restlessness scores on the visual analog scales
Time Frame
20, 40, 60, and 80 minutes s/p administration of medications, and again 48-72 hours later
Other Pre-specified Outcome Measures:
Title
QT prolongation caused by the administration of Haloperidol
Description
EKGs were performed prior to the administration of study meds and then again at the completion of the study.
Time Frame
2 hours after administration of Haldol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Gaffigan, MD
Organizational Affiliation
United States Naval Medical Center, Portsmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
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