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Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

University of Iowa logo

University of Iowa

Status

Terminated

Conditions

Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Treatments

Drug: Metoclopramide + diphenhydramine
Drug: Droperidol

Study type

Interventional

Funder types

Other

Identifiers

NCT01406860
201008798
University of Iowa

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

19 participants in 2 patient groups

Droperidol
Experimental group
Treatment:
Drug: Droperidol
Metoclopramide + Diphenhydramine
Active Comparator group
Treatment:
Drug: Metoclopramide + diphenhydramine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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