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Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children

This study is currently recruiting participants.
Verified July 2017 by Daniel Sing-Kwong Tsze, Columbia University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02358681
First Posted: February 9, 2015
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University
  Purpose

Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer.

The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children.

Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.


Condition Intervention Phase
Migraine Drug: Ketorolac, intranasal Drug: Ketorolac, intravenous Drug: Placebo, intravenous Drug: Placebo, intranasal Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial

Resource links provided by NLM:


Further study details as provided by Daniel Sing-Kwong Tsze, Columbia University:

Primary Outcome Measures:
  • Change in pain score after analgesic administration (Faces Pain Scale - Revised (FPS-R) [ Time Frame: 60 minutes ]
    Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration.


Secondary Outcome Measures:
  • Time to achieve clinically significant reduction in pain after analgesic administration (Pain score) [ Time Frame: 60 minutes ]
    Pain score will be assessed every 10 minutes after analgesic administration, until pain score decreases by 2/10 on the FPS-R)


Other Outcome Measures:
  • Adverse events [ Time Frame: 24 hours ]
    Adverse events will be assessed at the 1- and 2-hour assessments and the 24-hour follow up.

  • ED-based outcomes (Receipt of rescue medications during emergency department visit) [ Time Frame: 12 hours ]
    Receipt of rescue medications during emergency department visit

  • ED-based outcomes (Headache relief in emergency department) [ Time Frame: 2 hours ]
    Headache relief in emergency department

  • ED-based outcomes (Headache freedom in emergency department) [ Time Frame: 2 hours ]
    Headache freedom in emergency department

  • ED-based outcomes (Percentage improvement in pain score between baseline and one hour) [ Time Frame: 1 hour ]
    Percentage improvement in pain score between baseline and one hour

  • 24-hour follow up outcomes (Patient's assessment of efficacy and tolerability) [ Time Frame: 24 hours ]
    Patient's assessment of efficacy and tolerability

  • 24-hour follow up outcomes (Sustained headache freedom) [ Time Frame: 24 hours ]
    Sustained headache freedom

  • 24-hour follow up outcomes (Sustained headache relief) [ Time Frame: 24 hours ]
    Sustained headache relief

  • 24-hour follow up outcomes (Use of rescue medications after discharge from the ED.) [ Time Frame: 24 hours ]
    Use of rescue medications after discharge from the ED.


Estimated Enrollment: 80
Study Start Date: May 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketorolac, intranasal
  1. Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.
  2. Placebo, intravenous.
Drug: Ketorolac, intranasal
Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
Other Name: Toradol
Drug: Placebo, intravenous
Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
Active Comparator: Ketorolac, intravenous
  1. Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.
  2. Placebo, intranasal.
Drug: Ketorolac, intravenous
Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
Other Name: Toradol
Drug: Placebo, intranasal
Placebo of equal volume to IN ketorolac, to be administered by intranasal route.

Detailed Description:

Primary Aim: Determine whether intranasal (IN) ketorolac is non-inferior to intravenous (IV) ketorolac for reducing pain in children with acute migraine headaches. We hypothesize that IN ketorolac is non-inferior to IV ketorolac in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.

Secondary Aim: Determine whether the time to achieve a clinically significant reduction in pain after receiving IN ketorolac is non-inferior to IV ketorolac. We hypothesize that IN ketorolac is non-inferior to IV ketorolac in the time it takes to achieve a clinically significant reduction in pain.

We will conduct a prospective, double-blinded, randomized, non-inferiority, parallel 1:1 clinical trial of eligible children in a single urban pediatric ED. We will block randomize patients to receive either 1 mg/kg IN ketorolac and an IV placebo (study group A), or 0.5 mg/kg IV ketorolac and an IN placebo (study group B).

We will assess the patient's pain at baseline, and then in 10-minute intervals after administration of the study drug for 60 minutes. The patient will then be assessed at 2 hours and 24 hours after study drug administration for outcomes related to efficacy, function, and safety.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present to the emergency department with a migraine headache as defined by the modified Irma criteria. The modified Irma criteria are as follows: Headache episodes of 1-72 hours presenting with at least 3 of the following 6 criteria: moderate to severe episode of impaired daily activities; focal localization of headache; pulsatile description; nausea or vomiting or abdominal pain; photophobia or phonophobia or avoidance of light and noise; symptoms increasing with activity or resolving by rest.
  • Headache severity of moderate to severe pain (i.e. at least 4/10 on the Faces Pain Scale - Revised)
  • Requiring IV ketorolac as part of their headache treatment, as per their treating attending physician

Exclusion Criteria:

  • Contraindication to receiving ketorolac
  • Receipt of an NSAID within six hours of study drug administration
  • Presence of an intranasal obstruction that cannot be readily cleared
  • Inability to speak English or Spanish
  • Unable to complete self-report measures of pain or questionnaires
  • Critical illness
  • Frequent use of drugs for headache (i.e. regular intake of analgesics for acute headaches on more than 10 days per month).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358681


Contacts
Contact: Daniel S Tsze, MD, MPH 212-305-9825 dst2141@columbia.edu

Locations
United States, New York
NewYork Presbyterian Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
Contact: Daniel S Tsze, MD, MPH    212-305-9825    dst2141@columbia.edu   
Principal Investigator: Daniel S Tsze, MD, MPH         
Principal Investigator: Peter S Dayan, MD, MSc         
Sub-Investigator: Benjamin W Friedman, MD         
Sub-Investigator: Shannon E Babineau, MD         
Sponsors and Collaborators
Columbia University
Migraine Research Foundation
Investigators
Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
  More Information

Responsible Party: Daniel Sing-Kwong Tsze, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02358681     History of Changes
Other Study ID Numbers: AAAO1302
First Submitted: January 29, 2015
First Posted: February 9, 2015
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Daniel Sing-Kwong Tsze, Columbia University:
Intranasal
Ketorolac
Pediatric
Migraine
Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action