Evaluating Pharmacokinetics of Intranasal KetorolacPhase 1NCT02297906
Pharmacokinetics of Intranasal Ketorolac in Children
A Phase 1 study testing Ketorolac in people with Evaluating Pharmacokinetics of Intranasal Ketorolac and Pain, run by Columbia University at 1 site in United States.
Trial summary
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluating Pharmacokinetics of Intranasal Ketorolac, Pain
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 29 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.
Who cannot join
- Known allergy to ketorolac
- Contraindication to receiving ketorolac
- Receiving any NSAID within the past 6 hours
- Presence of an intranasal obstruction that cannot be readily cleared using suction or nose-blowing
- Inability to speak English or Spanish
- Critical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.
Read the detailed description
The intranasal (IN) route of administering medications is an effective means of delivering analgesics to children in a painless and minimally distressing manner, especially in comparison to traditional means of intravenous (IV) or intramuscular (IM) administration, which require a painful and distressing needle stick.
Ketorolac is an analgesic that is commonly administered to children, and can be given by the IN route, in addition to the IV and IM routes. However, the pharmacokinetics of intranasal ketorolac when administered in children has only been described in a limited fashion. The administration of IN ketorolac in children, using the proprietary SPRIX device, which atomizes a fixed amount of ketorolac, produces serum concentrations of ketorolac that are associated with analgesia. However, the concentrations of ketorolac achieved using a mucosal atomization device (MAD) has not yet been evaluated in children presenting to the emergency department. The MAD is a plastic device that attaches to the top of a syringe (see figure). The MAD is much more commonly used for atomizing medications; allows a variable dosage to be administered; and has been shown to be a means of effectively delivering other analgesics and sedatives intranasally.
The purpose of this study is to assess the pharmacokinetics of IN ketorolac when using a MAD to deliver the medication in children presenting to the emergency department. We will determine the maximum serum concentration achieved (Cmax), time to maximum serum concentration achieved (Tmax), and bioavailability (compared to IV ketorolac) when ketorolac is administered intranasally using a MAD.
- Being tested
- Ketorolac
- Keywords
- Intranasal, Ketorolac, Pharmacokinetics, Pediatric
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Non-steroidal anti-inflammatory drug
| Study group | Role | What they receive |
|---|---|---|
| Intranasal ketorolac | Experimental | Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intranasal route using a mucosal atomization device. Receives: Drug: Ketorolac |
| Intravenous ketorolac | Active comparator | Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intravenous route. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of intranasal ketorolac
Maximum serum concentration of ketorolac, after intranasal administration
Measured: 60 minutes
Secondary outcomes (2)
Tmax of intranasal ketorolac
Time to maximum serum concentration of ketorolac, after intranasal administration
Measured: 6 hours
Bioavailability of intranasal ketorolac
Bioavailability of intranasal ketorolac; expressed as a percentage (numerator = serum levels achieved by intranasal administration, denominator = serum levels achieved by intravenous administration)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Why it stopped: Enrolment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating Pharmacokinetics of Intranasal KetorolacStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- 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
- NCT02297906
- Sponsor's protocol ID
- AAAN5404
- Status last verified
- Jan 2019
- First submitted
- 14 Nov 2014
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intranasal Ketorolac in Children
- ClinicalTrials.gov ID
- NCT02297906
- Acronym / sponsor ID
- AAAN5404
- Keywords
- Intranasal, Ketorolac, Pharmacokinetics, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment issues
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.
Detailed description
The intranasal (IN) route of administering medications is an effective means of delivering analgesics to children in a painless and minimally distressing manner, especially in comparison to traditional means of intravenous (IV) or intramuscular (IM) administration, which require a painful and distressing needle stick.
Ketorolac is an analgesic that is commonly administered to children, and can be given by the IN route, in addition to the IV and IM routes. However, the pharmacokinetics of intranasal ketorolac when administered in children has only been described in a limited fashion. The administration of IN ketorolac in children, using the proprietary SPRIX device, which atomizes a fixed amount of ketorolac, produces serum concentrations of ketorolac that are associated with analgesia. However, the concentrations of ketorolac achieved using a mucosal atomization device (MAD) has not yet been evaluated in children presenting to the emergency department. The MAD is a plastic device that attaches to the top of a syringe (see figure). The MAD is much more commonly used for atomizing medications; allows a variable dosage to be administered; and has been shown to be a means of effectively delivering other analgesics and sedatives intranasally.
The purpose of this study is to assess the pharmacokinetics of IN ketorolac when using a MAD to deliver the medication in children presenting to the emergency department. We will determine the maximum serum concentration achieved (Cmax), time to maximum serum concentration achieved (Tmax), and bioavailability (compared to IV ketorolac) when ketorolac is administered intranasally using a MAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal ketorolac | Experimental | Drug: KetorolacKetorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intranasal route using a mucosal atomization device. |
| Intravenous ketorolac | Active comparator | Drug: KetorolacKetorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intravenous route. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.
Key exclusion criteria (6 listed)
- Known allergy to ketorolac
- Contraindication to receiving ketorolac
- Receiving any NSAID within the past 6 hours
- Presence of an intranasal obstruction that cannot be readily cleared using suction or nose-blowing
- Inability to speak English or Spanish
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 |
|---|---|---|
| KetorolacAlso: ToradolNon-steroidal anti-inflammatory drug | Drug | Intranasal ketorolac, Intravenous ketorolac |
Primary outcome
Cmax of intranasal ketorolac
Time frame: 60 minutes
Maximum serum concentration of ketorolac, after intranasal administration
2 secondary outcomes
Tmax of intranasal ketorolac
Time frame: 6 hours
Bioavailability of intranasal ketorolac
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: Enrolment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
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 1 study testing Ketorolac in people with Evaluating Pharmacokinetics of Intranasal Ketorolac and Pain, 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Jan 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolment issues). Results are not available in the source record.
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?
Cmax of intranasal ketorolac (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 17 Jan 2019.