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Pharmacokinetics of Intranasal Ketorolac in Children

Sponsor
Columbia University (Other)
Overall Status
Terminated
CT.gov ID
NCT02297906
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
33.9
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics of Intranasal Ketorolac in Children
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Nov 29, 2017
Actual Study Completion Date :
Nov 29, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intranasal ketorolac

Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intranasal route using a mucosal atomization device.

Drug: Ketorolac
Non-steroidal anti-inflammatory drug
Other Names:
  • Toradol

    		•
    Active Comparator: Intravenous ketorolac

    Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intravenous route.

    Drug: Ketorolac
    Non-steroidal anti-inflammatory drug
    Other Names:
  • Toradol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax of intranasal ketorolac [60 minutes]

      Maximum serum concentration of ketorolac, after intranasal administration

    Secondary Outcome Measures

    1. Tmax of intranasal ketorolac [6 hours]

      Time to maximum serum concentration of ketorolac, after intranasal administration

    2. Bioavailability of intranasal ketorolac [6 hours]

      Bioavailability of intranasal ketorolac; expressed as a percentage (numerator = serum levels achieved by intranasal administration, denominator = serum levels achieved by intravenous administration)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.
    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Presbyterian Morgan Stanley Children's Hospital New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Daniel S Tsze, MD, MPH, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics at CUMC, Columbia University
    ClinicalTrials.gov Identifier:
    NCT02297906
    Other Study ID Numbers:
    • AAAN5404
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Jan 17, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics at CUMC, Columbia University
    Intranasal
    Ketorolac
    Pharmacokinetics
    Pediatric
    Additional relevant MeSH terms:
    Ketorolac

    Study Results

    No Results Posted as of Jan 17, 2019