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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have enlarged tonsils and adenoids.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative pain management

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
43,513 Total Patients Enrolled
1 Trials studying Postoperative Pain
223 Patients Enrolled for Postoperative Pain

Media Library

Ketorolac (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05074056 — Phase 4
Postoperative Pain Research Study Groups: Ketorolac, Placebo
Postoperative Pain 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for participation in this medical experiment?

"To join this medical trial, applicants must suffer from adenotonsillar hypertrophy and be aged between 3 to 12 years old. The targeted recruitment is 200 participants in total."

Answered by AI

How many participants are being accepted into this medical research endeavor?

"Indeed. Clinicaltrials.gov's records demonstrate that this research project, which was initially uploaded on February 8th 2022, is actively recruiting participants. The study hopes to enroll 200 people from a single medical facility."

Answered by AI

What medical maladies is Ketorolac typically employed to alleviate?

"Ketorolac is commonly prescribed for treating ocular itching but can also serve as a remedy for pain, pupil dilation, and induction of nerve block."

Answered by AI

Does this trial encompass individuals over the age of 55?

"This trial requires participants aged between 3 and 12. For those under 18, there are 126 studies available, while 691 trials exist for patients over 65."

Answered by AI

Are there any opportunities to join this experiment at present?

"This is accurate. Clinicaltrials.gov displays that 200 patients are being sought for this medical trial, which was first posted on February 8th 2022 and recently updated on February 20th 2022. One single location will be administering the study to participants."

Answered by AI

Has the FDA sanctioned Ketorolac for usage?

"The safety profile of Ketorolac has been well established in a Phase 4 trial, resulting in its assessment on the Power team's scale being rated as 3."

Answered by AI

Could you inform me of any previous research done utilizing Ketorolac?

"At the moment, 38 medical trials are evaluating Ketorolac's effectiveness. Of those studies, 8 have reached Phase 3 status. The majority of these tests occur in Los Angeles; however, 57 other sites from across the US have begun to conduct their own investigations."

Answered by AI
~10 spots leftby Jun 2024