Nausea Clinical Trial
Official title:
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
Lead Sponsor | Collaborator |
---|---|
United States Naval Medical Center, Portsmouth |
United States,
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 |
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