Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

NCT01406860 | Terminated Results DMC

• 2 other identifiers: 201008798University of Iowa
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Keywords

Headaches; Migraines; Tension headaches; Cluster headaches

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Adverse Effects

  From the time when the treatment is initiated until the 24 hour follow-up phone survey

Study Arms (2)

Droperidol

EXPERIMENTAL

Drug: Droperidol

Metoclopramide + Diphenhydramine

ACTIVE COMPARATOR

Drug: Metoclopramide + diphenhydramine

Interventions

Droperidol DRUG

Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes

Droperidol

Metoclopramide + diphenhydramine DRUG

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.

Metoclopramide + Diphenhydramine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old to 65 years old, diagnosis of primary headache

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Cluster Headache; Headache; Migraine Disorders; Tension-Type Headache

Interventions

Droperidol; Metoclopramide; Diphenhydramine

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Ethylamines; Amines; Benzhydryl Compounds

Results Point of Contact

• Title: Brett Faine
• Organization: University of Iowa Hospitals and Clinics

brett-faine@uiowa.edu

3193108067

Study Officials

• Jon Van Heukelom, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Christopher Hogrefe, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Brett Faine, PharmD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: August 1, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 5, 2017
• Results First Posted: December 5, 2017

Record last verified: 2017-11

Locations

US (1)