Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Not Applicable

Terminated

• Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
• Interventions: Drug: Droperidol; Drug: Metoclopramide + diphenhydramine

• Registration Number: NCT01406860
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-22
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2017-06-21
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Results First Posted: 2017-12-05
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Droperidol	Droperidol	-
Metoclopramide + Diphenhydramine	Metoclopramide + diphenhydramine	-

Primary Outcome Measures

Name	Time	Method
Pain Scale (Numerical Rating Scale for Pain)	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

Name	Time	Method
Length of Stay	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	24 hours after discharge from ED	24 hour pain score (follow-up phone call)
Adverse Effects	From the time when the treatment is initiated until the 24 hour follow-up phone survey	Frequency of adverse effects in each arm

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States