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

This study has been withdrawn prior to enrollment.
(Drug is backordered;)
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01534806
First received: November 8, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Ketorolac
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • number of patients requiring additional treatment interventions by the treating physician [ Time Frame: while in the emergency department, an expected average of 2 hours. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • recurrence of headache [ Time Frame: 48-72 hours after discharge ] [ Designated as safety issue: No ]
  • side effects of medications [ Time Frame: 48-72 hours after discharge ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534806

Locations
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: sarah Kline-Krammes, MD Akron Children's Hospital
  More Information

Publications:
Trottier ED, Bailey B, Lucas N, Lortie A. Prochlorperazine in children with migraine: a look at its effectiveness and rate of akathisia. Am J Emerg Med.2011.

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01534806     History of Changes
Other Study ID Numbers: 110808
Study First Received: November 8, 2011
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketorolac
Ketorolac Tromethamine
Prochlorperazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 16, 2014