Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Primary Headaches (Includes Migraines, Tension, Cluster Headaches) Clinical Trial

Official title:

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01406860
• Other study ID #: 201008798
• Secondary ID: University of Io
• Status: Terminated
• Phase: N/A
• First received: September 22, 2010
• Last updated: November 27, 2017
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Migraine Disorders
• Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Intervention

Drug:
• Droperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	24 Hour Pain Score	24 hour pain score (follow-up phone call)	24 hours after discharge from ED
Secondary	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