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Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

NCT03453541 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-10-15

No results posted yet for this study

Summary

This prospective, randomized, double blinded study is designed to compare the bleeding rates of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients ages 2-18.

Conditions

  • Analgesic Adverse Reaction

Interventions

DRUG

Ketorolac Tromethamine

Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.

DRUG

0.9% Normal Saline

0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Farzana Afroze, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

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 NCT03453541 on ClinicalTrials.gov