Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Study Overview
=================
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.

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

Conditions
-----------------
Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Intervention / Treatment
-----------------
* Drug: Droperidol
* Drug: Metoclopramide + diphenhydramine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Droperidol<br> | Drug: Droperidol<br>* Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes<br>|
| Active Comparator: Metoclopramide + Diphenhydramine<br> | Drug: Metoclopramide + diphenhydramine<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headaches, Migraines, Tension headaches, Cluster headaches