Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department - Full Text View

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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Prochlorperazine Prochlorperazine maleate Prochlorperazine edisylate Ketorolac Ketorolac tromethamine

U.S. FDA Resources

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 ]

Estimated Enrollment:	70
Study Start Date:	April 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	May 2013 (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:

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.

Contacts and Locations

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:

Kan L, Nagelberg J, Maytal J. Headaches in a pediatric emergency department: etiology, imaging, and treatment. Headache. 2000 Jan;40(1):25-9.

Lewis DW, Qureshi F. Acute headache in children and adolescents presenting to the emergency department. Headache. 2000 Mar;40(3):200-3.

Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):646-57.

Lewis DW. Toward the definition of childhood migraine. Curr Opin Pediatr. 2004 Dec;16(6):628-36. Review.

Hämäläinen ML, Hoppu K, Valkeila E, Santavuori P. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo-controlled, crossover study. Neurology. 1997 Jan;48(1):103-7.

Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6.

Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6.

Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med. 1998 Jun;5(6):573-6.

Kabbouche MA, Vockell AL, LeCates SL, Powers SW, Hershey AD. Tolerability and effectiveness of prochlorperazine for intractable migraine in children. Pediatrics. 2001 Apr;107(4):E62.

Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62.

Trottier ED, Bailey B, Dauphin-Pierre S, Gravel J. Clinical outcomes of children treated with intravenous prochlorperazine for migraine in a pediatric emergency department. J Emerg Med. 2010 Aug;39(2):166-73. Epub 2009 Jan 15.

McGrath PA. The multidimensional assessment and management of recurrent pain syndromes in children. Behav Res Ther. 1987;25(4):251-62.

Chambers CT, Giesbrecht K, Craig KD, Bennett SM, Huntsman E. A comparison of faces scales for the measurement of pediatric pain: children's and parents' ratings. Pain. 1999 Oct;83(1):25-35.

Responsible Party:	Sarah Kline-Krammes, Principal Investigator, Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT01534806 History of Changes
Other Study ID Numbers:	110808
Study First Received:	November 8, 2011
Last Updated:	December 17, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:

Migraine

Additional relevant MeSH terms:

Emergencies
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Prochlorperazine
Ketorolac
Ketorolac Tromethamine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on May 19, 2013