Droperidol Versus Metoclopramide for the Treatment of Primary Headaches
Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Intervention: Droperidol (Drug); Metoclopramide (Drug); Diphenhydramine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
Jon Van Heukelom, MD, Principal Investigator, Affiliation: University of Iowa
Christopher Hogrefe, MD, Principal Investigator, Affiliation: University of Iowa
Brett Faine, PharmD, Principal Investigator, Affiliation: University of Iowa
Summary
The purpose of this study is to determine if droperidol is equally as effective as
metoclopramide for treatment of primary headaches in the Emergency Department.
Clinical Details
Official title: Droperidol Versus Metoclopramide for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain Scale
Secondary outcome: Length of Stay24 hour pain score Adverse Effects
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years old to 65 years old, diagnosis of primary headache
Exclusion Criteria:
- Allergy to study medications, pregnant, breast-feeding, prisoners, non-english
speaking, not eligible to receive droperidol based on ED protocol (see below),
patients in whom head trauma, infection, vascular disorders, and disorders of facial
or cranial structures are suspected
ED Droperidol Protocol
Droperidol must NOT be used in patients with any of the following:
- Known or suspected QT prolongation, including congenital long QT syndrome
- Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic
heart disease, myocardial infarction, bradycardia (< 50 bpm)]
- History of the following:
- Renal failure
- Cerebrovascular disease
- Diabetes or hypoglycemia
- Alcoholism/alcohol abuse
- Pituitary insufficiency
- Hypothyroidism
- Hypothermia
- Anorexia
- Advanced age (>65 yrs)
- Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or
other medications known to prolong the QTc interval.
Locations and Contacts
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
Additional Information
Starting date: July 2011
Last updated: January 14, 2013
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