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Droperidol Versus Metoclopramide for the Treatment of Primary Headaches

This study has been terminated.
(lack of enrollment/drug shortages)
Sponsor:
Information provided by (Responsible Party):
Brett A Faine, University of Iowa
ClinicalTrials.gov Identifier:
NCT01406860
First received: September 22, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
 Drug: Droperidol
Drug: Metoclopramide
Drug: Diphenhydramine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Droperidol Versus Metoclopramide for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 19
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Droperidol Drug: Droperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Active Comparator: Metoclopramide Drug: Metoclopramide
Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.
Diphenhydramine 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406860

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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
  More Information

No publications provided

Responsible Party: Brett A Faine, Clinical Pharmacy Specialist, University of Iowa
ClinicalTrials.gov Identifier: NCT01406860     History of Changes
Other Study ID Numbers: 201008798, University of Iowa
Study First Received: September 22, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Headaches
Migraines
Tension headaches
Cluster headaches

Additional relevant MeSH terms:
Cluster Headache
Headache
Migraine Disorders
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diphenhydramine
Droperidol
Metoclopramide
 Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013