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Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

This study has been terminated.
(lack of enrollment/drug shortages)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406860
First Posted: August 1, 2011
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
Brett A Faine, University of Iowa
September 22, 2010
August 1, 2011
June 21, 2017
December 5, 2017
December 5, 2017
July 2011
July 2012   (Final data collection date for primary outcome measure)
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
Pain Scale [ Time Frame: Change in pain scores at 60 minutes as measured on the Numerical Rating Scale for Pain (NRS) ]
Complete list of historical versions of study NCT01406860 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 24 Hour Pain Score [ Time Frame: 24 hours after discharge from ED ]
    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 ]
    Frequency of adverse effects in each arm
Same as current
Not Provided
Not Provided
 
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
  • Drug: Droperidol
    Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
  • 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.
  • Experimental: Droperidol
    Intervention: Drug: Droperidol
  • Active Comparator: Metoclopramide + Diphenhydramine
    Intervention: Drug: Metoclopramide + diphenhydramine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01406860
201008798
University of Iowa
Yes
Not Provided
Not Provided
Brett A Faine, University of Iowa
University of Iowa
Not Provided
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
University of Iowa
November 2017

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