Droperidol Versus Metoclopramide for the Treatment of Primary Headaches

This study is currently recruiting participants.

Verified July 2011 by University of Iowa

Sponsor:

Information provided by:

University of Iowa

ClinicalTrials.gov Identifier:

NCT01406860

First received: September 22, 2010

Last updated: July 29, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 22, 2010

Last Updated Date

July 29, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain Scale [ Time Frame: Change in pain scores at 60 minutes as measured on the Numerical Rating Scale for Pain (NRS) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406860 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Length of Stay [ Time Frame: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes) ] [ Designated as safety issue: No ]
24 hour pain score [ Time Frame: 24 hours after discharge from ED ] [ Designated as safety issue: No ]
24 hour pain score (follow-up phone call)
Adverse Effects [ Time Frame: From the time when the treatment is initiated until the 24 hour follow-up phone survey ] [ Designated as safety issue: Yes ]
Frequency of adverse effects in each arm

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Droperidol Versus Metoclopramide for the Treatment of Primary Headaches

Official Title ^ICMJE

Droperidol Versus Metoclopramide for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Intervention ^ICMJE

Drug: Droperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Drug: Metoclopramide
Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.
Drug: Diphenhydramine
Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.

Study Arm (s)

Experimental: Droperidol
Intervention: Drug: Droperidol
Active Comparator: Metoclopramide
Intervention: Drug: Metoclopramide
Diphenhydramine
Intervention: Drug: Diphenhydramine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jon Van Heukelom, MD		jon-vanheukelom@uiowa.edu
Contact: Brett Faine, PharmD		brett-faine@uiowa.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01406860

Other Study ID Numbers ^ICMJE

201008798, University of Iowa

Has Data Monitoring Committee

Yes

Responsible Party

Jon Van Heukelom, MD, University of Iowa Hospitals and Clinics

Study Sponsor ^ICMJE

University of Iowa

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Jon Van Heukelom, MD	University of Iowa
Principal Investigator:	Christopher Hogrefe, MD	University of Iowa
Principal Investigator:	Brett Faine, PharmD	University of Iowa

Information Provided By

University of Iowa

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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