Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Ketorolac, intranasal (Drug); Ketorolac, intravenous (Drug); Placebo, intravenous (Drug); Placebo, intranasal (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s):
Daniel S Tsze, MD, MPH, Principal Investigator, Affiliation: Columbia University
Overall contact:
Daniel S Tsze, MD, MPH, Phone: 212-305-9825, Email: dst2141@columbia.edu
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.
Clinical Details
Official title: Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in pain score after analgesic administration (Faces Pain Scale - Revised (FPS-R)
Secondary outcome: Time to achieve clinically significant reduction in pain after analgesic administration (Pain score)
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
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
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).
Locations and Contacts
Daniel S Tsze, MD, MPH, Phone: 212-305-9825, Email: dst2141@columbia.edu
NewYork Presbyterian Morgan Stanley Children's Hospital, New York, New York 10032, United States; Recruiting
Daniel S Tsze, MD, MPH, Phone: 212-305-9825, Email: dst2141@columbia.edu
Daniel S Tsze, MD, MPH, Principal Investigator
Peter S Dayan, MD, MSc, Principal Investigator
Benjamin W Friedman, MD, Sub-Investigator
Shannon E Babineau, MD, Sub-Investigator
Additional Information
Starting date: May 2015
Last updated: May 6, 2015
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