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Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

NCT ID: NCT01406860

Last Updated: 2017-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Keywords

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Headaches Migraines Tension headaches Cluster headaches

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Droperidol

Group Type EXPERIMENTAL

Droperidol

Intervention Type DRUG

Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes

Metoclopramide + Diphenhydramine

Group Type ACTIVE_COMPARATOR

Metoclopramide + diphenhydramine

Intervention Type DRUG

Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + 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.

Interventions

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Droperidol

Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes

Intervention Type DRUG

Metoclopramide + diphenhydramine

Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Brett A Faine

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Van Heukelom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Christopher Hogrefe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Brett Faine, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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University of Iowa

Identifier Type: -

Identifier Source: secondary_id

201008798

Identifier Type: -

Identifier Source: org_study_id