Trial record 3 of 28 for:    INAPSINE OR MCN-JR-4749 OR DROPERIDOL OR DROLEPTAN OR Dridol OR R-4749

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406860
Recruitment Status : Terminated (lack of enrollment/drug shortages)
First Posted : August 1, 2011
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Brett A Faine, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Primary Headaches (Includes Migraines, Tension, Cluster Headaches) Drug: Droperidol Drug: Metoclopramide + diphenhydramine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Droperidol Drug: Droperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes

Active Comparator: Metoclopramide + Diphenhydramine 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.

Primary Outcome Measures :
  1. Pain Scale (Numerical Rating Scale for Pain) [ Time Frame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS) ]
    Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain

Secondary Outcome Measures :
  1. 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) ]
  2. 24 Hour Pain Score [ Time Frame: 24 hours after discharge from ED ]
    24 hour pain score (follow-up phone call)

  3. Adverse Effects [ Time Frame: From the time when the treatment is initiated until the 24 hour follow-up phone survey ]
    Frequency of adverse effects in each arm

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406860

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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

Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa Identifier: NCT01406860     History of Changes
Other Study ID Numbers: 201008798
University of Iowa
First Posted: August 1, 2011    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: November 2017

Keywords provided by Brett A Faine, University of Iowa:
Tension headaches
Cluster headaches

Additional relevant MeSH terms:
Migraine Disorders
Cluster Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action