search
Back to results

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Primary Purpose

Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Droperidol
Metoclopramide + diphenhydramine
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Headaches (Includes Migraines, Tension, Cluster Headaches) focused on measuring Headaches, Migraines, Tension headaches, Cluster headaches

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Droperidol

Metoclopramide + Diphenhydramine

Arm Description

Outcomes

Primary Outcome Measures

Pain Scale (Numerical Rating Scale for Pain)
Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain

Secondary Outcome Measures

Length of Stay
24 Hour Pain Score
24 hour pain score (follow-up phone call)
Adverse Effects
Frequency of adverse effects in each arm

Full Information

First Posted
September 22, 2010
Last Updated
November 27, 2017
Sponsor
University of Iowa
search

1. Study Identification

Unique Protocol Identification Number
NCT01406860
Brief Title
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches
Official Title
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment/drug shortages
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Keywords
Headaches, Migraines, Tension headaches, Cluster headaches

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Droperidol
Arm Type
Experimental
Arm Title
Metoclopramide + Diphenhydramine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Droperidol
Intervention Description
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Intervention Type
Drug
Intervention Name(s)
Metoclopramide + diphenhydramine
Intervention Description
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 Measure Information:
Title
Pain Scale (Numerical Rating Scale for Pain)
Description
Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain
Time Frame
Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Secondary Outcome Measure Information:
Title
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)
Title
24 Hour Pain Score
Description
24 hour pain score (follow-up phone call)
Time Frame
24 hours after discharge from ED
Title
Adverse Effects
Description
Frequency of adverse effects in each arm
Time Frame
From the time when the treatment is initiated until the 24 hour follow-up phone survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Van Heukelom, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Hogrefe, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brett Faine, PharmD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

We'll reach out to this number within 24 hrs