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.
Verified date | November 2017 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
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 |