Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in t… (NCT02098499) | Clinical Trial Compass
WithdrawnPhase 4
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
Stopped: No recruitment occurred and PI retired
United States0Started 2013-06-12
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT02098499
SponsorUnited States Naval Medical Center, Portsmouth