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.

Study Overview

• Status: Terminated
• Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
• Intervention / Treatment: Drug: Droperidol; Drug: Metoclopramide + diphenhydramine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scale (Numerical Rating Scale for Pain)	Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain	Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Jon Van Heukelom, MD, University of Iowa; Principal Investigator: Brett Faine, PharmD, University of Iowa

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (ESTIMATE): August 1, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Headaches; Migraines; Tension headaches; Cluster headaches
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Metoclopramide; Droperidol
• Other Study ID Numbers: 201008798; University of Iowa