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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketorolac, intranasal
Ketorolac, intravenous
Placebo, intravenous
Placebo, intranasal
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Intranasal, Ketorolac, Pediatric, Migraine, Headache

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 1-168 hours (7 days) 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 fluids and any IV medication (for example: ketorolac, metoclopramide, prochlorperazine, ondansetron) 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).

Sites / Locations

  • NewYork Presbyterian Morgan Stanley Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketorolac, intranasal

Ketorolac, intravenous

Arm Description

Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose. Placebo, intravenous.

Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose. Placebo, intranasal.

Outcomes

Primary Outcome Measures

Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R)
Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome).

Secondary Outcome Measures

Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score)
Pain score will be assessed at 10, 30, 60 and 120 minutes after analgesic administration, until pain score decreases by 2/10 on the Faces Pain Scale - Revised (FPS-R). The FPS-R is scored from 0 (no pain) to 10 (maximal pain, i.e. worst outcome)

Full Information

First Posted
January 29, 2015
Last Updated
January 3, 2022
Sponsor
Columbia University
Collaborators
Migraine Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02358681
Brief Title
Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Official Title
Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Migraine Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 there is a difference in time to achieve a clinically significant reduction in pain after receiving IN ketorolac compared to IV ketorolac. We hypothesize that there is no difference between IN ketorolac and 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 at 10 minutes, 30 minutes and 60 minutes after administration of the study drug. The patient will then be assessed at 2 hours and 24 hours after study drug administration for outcomes related to efficacy, function, and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Intranasal, Ketorolac, Pediatric, Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac, intranasal
Arm Type
Experimental
Arm Description
Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose. Placebo, intravenous.
Arm Title
Ketorolac, intravenous
Arm Type
Active Comparator
Arm Description
Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose. Placebo, intranasal.
Intervention Type
Drug
Intervention Name(s)
Ketorolac, intranasal
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
Intervention Type
Drug
Intervention Name(s)
Ketorolac, intravenous
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
Intervention Type
Drug
Intervention Name(s)
Placebo, intravenous
Intervention Description
Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
Intervention Type
Drug
Intervention Name(s)
Placebo, intranasal
Intervention Description
Placebo of equal volume to IN ketorolac, to be administered by intranasal route.
Primary Outcome Measure Information:
Title
Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R)
Description
Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome).
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score)
Description
Pain score will be assessed at 10, 30, 60 and 120 minutes after analgesic administration, until pain score decreases by 2/10 on the Faces Pain Scale - Revised (FPS-R). The FPS-R is scored from 0 (no pain) to 10 (maximal pain, i.e. worst outcome)
Time Frame
10, 30, 60 and 120 minutes
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse events will be assessed at the 1- and 2-hour assessments and the 24-hour follow up.
Time Frame
24 hours
Title
Number of Participants Who Received Rescue Medications During Emergency Department Visit
Description
Rescue medication defined as an additional parenteral analgesic administered in response to inadequate improvement in pain. Rescue medication was administered when deemed clinically indicated by the treating clinician.
Time Frame
12 hours
Title
Number of Participants Who Experienced Headache Relief During Emergency Department Visit
Description
Headache relief defined as change of the patient's headache pain intensity from severe to moderate to either mild or none, without receipt of rescue medications.
Time Frame
2 hours
Title
Number of Participants Who Experienced Headache Freedom During Emergency Department Visit
Description
Headache freedom defined as achieving a headache pain intensity of "none", without receipt of rescue medications.
Time Frame
2 hours
Title
Percentage Change in Pain Score Between Baseline and One Hour
Description
Percentage change in pain score between baseline and one hour after study medication administration. Pain measured using the Faces Pain Scale - Revised (FPS-R), which is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome). Positive values (i.e. percentage change) indicate a DECREASE (i.e. improvement) in pain intensity.
Time Frame
1 hour
Title
Number of Participants Who Reported Positive Overall Efficacy and Tolerability at 24-hour Follow-up
Description
Patient's assessment of overall efficacy and tolerability was assessed by asking the question, "The next time you come to the emergency department with a headache or migraine, do you want to be given the same medication?". A "yes" response was considered positive assessment of overall efficacy and tolerability.
Time Frame
24 hours
Title
Number of Participants Who Reported Sustained Headache Freedom at 24-hour Follow-up
Description
Sustained headache freedom defined as achieving headache freedom (i.e. headache pain intensity of "none"), and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge.
Time Frame
24 hours
Title
Number of Participants Who Reported Sustained Headache Relief at 24-hour Follow-up
Description
Sustained headache relief defined as achieving headache relief (i.e. headache pain intensity of "mild" or "none") and maintaining this level for 24 hours without the use of rescue medications after emergency department discharge.
Time Frame
24 hours
Title
Number of Participants Who Used Rescue Medication(s) Within 24 Hours After Emergency Department Discharge
Description
Rescue medications used after emergency department discharged defined as an analgesic taken by the participant at home to reduce pain associated with their headache.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 1-168 hours (7 days) 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 fluids and any IV medication (for example: ketorolac, metoclopramide, prochlorperazine, ondansetron) 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Tsze, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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