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The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

NCT01363076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-16

Study results available
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Summary

This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit.

Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 kg) or 30 mg (weight \> or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.

Conditions

  • Postoperative Pain

Interventions

DRUG

Ketorolac Tromethamine

Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg.

DRUG

Ketorolac Tromethamine

Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • Lincoln Bynum, MD · ICON Developmental Solutions

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-01-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363076 on ClinicalTrials.gov