MigrainePhase 3NCT02358681
Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
A Phase 3 study testing Ketorolac, intranasal and Ketorolac, intravenous in people with Migraine, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Ketorolac, intranasal and Ketorolac, intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2015to 31 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Ketorolac, intranasal, Ketorolac, intravenous, Placebo, intravenous, Placebo, intranasal
- Keywords
- Intranasal, Ketorolac, Pediatric, Migraine, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac, intranasalDrug
Also called Toradol
Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
Ketorolac, intravenousDrug
Also called Toradol
Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
Placebo, intravenousDrug
Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
Placebo, intranasalDrug
Placebo of equal volume to IN ketorolac, to be administered by intranasal route.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac, intranasal | Experimental | 1. Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose.
2. Placebo, intravenous. Receives: Drug: Ketorolac, intranasal; Drug: Placebo, intravenous |
| Ketorolac, intravenous | Active comparator | 1. Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose.
2. Placebo, intranasal. Receives: Drug: Ketorolac, intravenous; Drug: Placebo, intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 minutes
Secondary outcomes (1)
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)
Measured: 10, 30, 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start16 Jun 2015
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Migraine Research Foundation
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358681
- Sponsor's protocol ID
- AAAO1302
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2015
- Last updated
- 12 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT02358681
- Acronym / sponsor ID
- AAAO1302
- Conditions
- Migraine
- Keywords
- Intranasal, Ketorolac, Pediatric, Migraine, Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Migraine Research Foundation
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac, intranasal | Experimental | Drug: Ketorolac, intranasal, Drug: Placebo, intravenous1. Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose. 2. Placebo, intravenous. |
| Ketorolac, intravenous | Active comparator | Drug: Ketorolac, intravenous, Drug: Placebo, intranasal1. Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose. 2. Placebo, intranasal. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac, intranasalAlso: ToradolKetorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route. | Drug | Ketorolac, intranasal |
| Ketorolac, intravenousAlso: ToradolKetorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route. | Drug | Ketorolac, intravenous |
| Placebo, intravenousPlacebo of equal volume to IV ketorolac, to be administered by intravenous route. | Drug | Ketorolac, intranasal |
| Placebo, intranasalPlacebo of equal volume to IN ketorolac, to be administered by intranasal route. | Drug | Ketorolac, intravenous |
Primary outcome
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. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome).
1 secondary outcome
Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score)
Time frame: 10, 30, 60 and 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac, intranasal and Ketorolac, intravenous in people with Migraine, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.