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

June 23, 2014 updated by: Akron Children's Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
  2. 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:

  1. Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
  2. Patients unable to complete the pain scale.
  3. Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
  4. Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
  5. Female patients with a positive urine HCG point of care test
  6. 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.
  7. Patients who received prochlorperazine or ketorolac in the past 48 hours.
  8. Patients who had previously been randomized in this study in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients achieving complete resolution of the headache while in the emergency department.
Time Frame: while in the emergency department, an expected average of 2 hours.
while in the emergency department, an expected average of 2 hours.
number of patients requiring additional treatment interventions by the treating physician
Time Frame: while in the emergency department, an expected average of 2 hours.
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
Time Frame: while in the emergency department, an expected average of 2 hours.
while in the emergency department, an expected average of 2 hours.
recurrence of headache
Time Frame: 48-72 hours after discharge
48-72 hours after discharge
side effects of medications
Time Frame: 48-72 hours after discharge
48-72 hours after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akron Children's Hospital

Investigators

  • Principal Investigator: sarah Kline-Krammes, MD, Akron Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Ketorolac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe