Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this combination of medications treats not only the pain but also the associated gastrointestinal symptoms of migraine. The main outcome of this study is the reduction in the patient's pain score at 60 minutes from administration of the study medications. Secondary outcomes include the number of patients achieving complete resolution of the headache while in the ED, the number of patients requiring additional treatment interventions by the treating physician, the number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge, and side effects of the medications.

Official Title
-----------------
A Randomized Double Blinded Study Comparing Use of Prochlorperazine Versus Prochlorperazine and Ketorolac in the Treatment of Pediatric Migraine in the Emergency Department

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information. Exclusion Criteria: Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen Patients unable to complete the pain scale. Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen. Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma Female patients with a positive urine HCG point of care test Patients with diagnosis of or suspected to have chronic daily headaches defined as a headache lasting at least 4 hours for more than 15 days a month for the past 3 months. Patients who received prochlorperazine or ketorolac in the past 48 hours. Patients who had previously been randomized in this study in the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketorolac<br> | Drug: Ketorolac<br>* Ketorolac(0.5mg/kg) IV push<br>|
| Placebo Comparator: Placebo<br>Placebo IV push | Drug: Placebo<br>* Sodium Chloride 0.9% - 10 mL IV push<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the patient's pain score at 60 minutes from administration of the study medications |  | 60 minutes from administration of the study medications | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients achieving complete resolution of the headache while in the emergency department. |  | while in the emergency department, an expected average of 2 hours. | 
| number of patients requiring additional treatment interventions by the treating physician |  | while in the emergency department, an expected average of 2 hours. | 
| number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia |  | while in the emergency department, an expected average of 2 hours. | 
| recurrence of headache |  | 48-72 hours after discharge | 
| side effects of medications |  | 48-72 hours after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine