Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 476 for:    KETOROLAC
Previous Study | Return to List | Next Study

Pharmacokinetics of Intranasal Ketorolac 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297906
Recruitment Status : Terminated (Enrolment issues)
First Posted : November 21, 2014
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

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
Evaluating Pharmacokinetics of Intranasal Ketorolac Pain Drug: Ketorolac 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2015
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

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 Name: 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 Name: Toradol




Primary Outcome Measures :
  1. Cmax of intranasal ketorolac [ Time Frame: 60 minutes ]
    Maximum serum concentration of ketorolac, after intranasal administration


Secondary Outcome Measures :
  1. Tmax of intranasal ketorolac [ Time Frame: 6 hours ]
    Time to maximum serum concentration of ketorolac, after intranasal administration

  2. Bioavailability of intranasal ketorolac [ Time Frame: 6 hours ]
    Bioavailability of intranasal ketorolac; expressed as a percentage (numerator = serum levels achieved by intranasal administration, denominator = serum levels achieved by intravenous administration)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02297906


Locations
Layout table for location information
United States, New York
New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Daniel S Tsze, MD, MPH Columbia University

Layout table for additonal information
Responsible Party: Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics at CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT02297906     History of Changes
Other Study ID Numbers: AAAN5404
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Daniel S Tsze, MD, MPH, Columbia University:
Intranasal
Ketorolac
Pharmacokinetics
Pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action