Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
|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.|
|ClinicalTrials.gov Identifier: NCT02358681|
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : April 10, 2018
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 or disease||Intervention/treatment||Phase|
|Migraine||Drug: Ketorolac, intranasal Drug: Ketorolac, intravenous Drug: Placebo, intravenous Drug: Placebo, intranasal||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Ketorolac, intranasal
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
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.
- 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.
- 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)
- 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.
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
|Contact: Daniel S Tsze, MD, MPHemail@example.com|
|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 firstname.lastname@example.org|
|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|
|Principal Investigator:||Daniel S Tsze, MD, MPH||Columbia University|