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Nonsteroidal Anti-inflammatory Drug

Ketorolac for Post-Tonsillectomy Pain in Children

Phase 4
Waitlist Available
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adenotonsillar hypertrophy
Be younger than 18 years old
Must not have
Severe Obstructive sleep apnea
Child < 3 years old and > 12 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two hours
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will study whether ketorolac can help manage pain post-tonsillectomy in children and potentially lessen the amount of opioids needed.

Who is the study for?
This trial is for healthy children aged between 3 and 12 years with enlarged tonsils, experiencing obstructive sleep apnea or postoperative pain. It's not suitable for those under 3 or over 12, with severe sleep apnea, kidney disease, or liver disease.
What is being tested?
The study tests the effectiveness of Ketorolac in reducing pain after tonsil removal surgery in kids. It aims to see if this drug can help lessen the need for opioids during recovery.
What are the potential side effects?
Ketorolac may cause side effects such as stomach pain, bleeding, ulcers, headaches, dizziness, and potential risks to kidneys or liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have enlarged tonsils and adenoids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with severe obstructive sleep apnea.
Select...
My child is not between 3 and 12 years old.
Select...
I have a long-term liver condition.
Select...
I have chronic kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and two hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative pain management

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetorolacExperimental Treatment1 Intervention
A double-blinded number of children will get one dose of intravenous 0.5 mg/kg (max dose 30mg) ketorolac intraoperatively.
Group II: PlaceboPlacebo Group1 Intervention
A double-blinded number of children will get one dose of intravenous placebo intraoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
40,881 Total Patients Enrolled

Media Library

Ketorolac (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05074056 — Phase 4
Obstructive Sleep Apnea Research Study Groups: Ketorolac, Placebo
Obstructive Sleep Apnea Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT05074056 — Phase 4
Ketorolac (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074056 — Phase 4
~4 spots leftby Dec 2024
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