NCT02297906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

November 14, 2014

Last Update Submit

January 15, 2019

Conditions

Evaluating Pharmacokinetics of Intranasal KetorolacPain

Keywords

IntranasalKetorolacPharmacokineticsPediatric

Outcome Measures

Primary Outcomes (1)

  • Cmax of intranasal ketorolac

    Maximum serum concentration of ketorolac, after intranasal administration

    60 minutes

Secondary Outcomes (2)

  • Tmax of intranasal ketorolac

    6 hours

  • Bioavailability of intranasal ketorolac

    6 hours

Study Arms (2)

Intranasal ketorolac

EXPERIMENTAL

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

Drug: Ketorolac

Intravenous ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

KetorolacDRUG

Non-steroidal anti-inflammatory drug

Also known as: Toradol
Intranasal ketorolacIntravenous ketorolac

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pain

Interventions

KetorolacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Daniel S Tsze, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics at CUMC

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 21, 2014

Study Start

February 1, 2015

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

US(1)