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Ketorolac for Post Adenotonsillectomy Pain

Phase 4

Waitlist Available

Led By Laura Gilbertson, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sleep disordered breathing or obstructive sleep apnea

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until pacu discharge (typically within 3 hours)

Awards & highlights

Study Summary

This trial will compare how well two different pain management plans work for kids having surgery to remove their tonsils and adenoids. One group of kids will get a drug called ketorolac in addition to the usual care. The other group will just get the usual care. The researchers think that giving ketorolac at the end of the surgery, once the bleeding has stopped, might let them give less morphine later on in the recovery room.

Who is the study for?

This trial is for children with obstructive sleep apnea undergoing adenotonsillectomy at Children's Healthcare of Atlanta Egleston. Participants must have a diagnosis of sleep disordered breathing, and their parent or guardian must consent to the study. Kids with coagulation defects, renal impairment, or on long-term NSAID therapy cannot join.Check my eligibility

What is being tested?

The study tests if Ketorolac can reduce the need for morphine after surgery in kids with sleep apnea. It compares two groups: one receiving Ketorolac plus standard care and another getting only standard care post-adenotonsillectomy.See study design

What are the potential side effects?

Ketorolac may cause side effects like stomach pain, bleeding, kidney problems, and allergic reactions. Since it's given to reduce opioid use (morphine), it might help lessen opioid-related side effects such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sleep apnea or similar sleep breathing issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until pacu discharge (typically within 3 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until pacu discharge (typically within 3 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until pacu discharge (typically within 3 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

Morphine

Secondary outcome measures

Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score

Incidence of Post-Tonsillectomy Bleeding

Pain Medication Administration

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KetorolacExperimental Treatment2 Interventions

Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved

Group II: Standard of CareActive Control1 Intervention

Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

FDA approved

Ketorolac

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,644 Previous Clinical Trials

2,564,368 Total Patients Enrolled

Laura Gilbertson, MDPrincipal Investigator - Emory University

Emory University

1 Previous Clinical Trials

120 Total Patients Enrolled

Frequently Asked Questions

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

In what ways is Ketorolac typically employed therapeutically?

"Ketorolac is primarily used to remedy synovitis, yet it has also proven effective in managing ophthalmia and sympathetic branch retinal vein occlusion. Additionally, macular edema can be treated with this medication."

Answered by AI

Am I eligible to participate in this medical trial?

"Interested candidates will need to meet the criteria of having obstructive sleep apnea and falling between 2-18 years old in order be accepted into this trial. The desired number of participants is 120 individuals."

Answered by AI

What other scientific experiments have been conducted involving Ketorolac?

"Presently, there are 815 investigations into ketorolac; 192 of those being in the last phase. While Boston, Massachusetts is a hub for these studies, participation locations span 19251 unique sites."

Answered by AI

Is the Food and Drug Administration recognizing Ketorolac as a viable therapeutic option?

"Power gave Ketorolac a score of 3 as it has been authorized for use and is undergoing Phase 4 clinical trials."

Answered by AI

How many participants have been enlisted for this research effort?

"Affirmative. Information on clinicaltrials.gov indicates that this medical study is presently searching for volunteers. The trial was first advertised on July 19th 2018, and the most recent update occurred August 29th 2022. This experiment requires 120 participants from two different areas to be enrolled."

Answered by AI

Does the enrollment criteria for this research include octogenarians?

"This research requires participants aged between 2 and 18 years old. For context, there are 180 studies for younger people in this age bracket and 893 for those over 65."

Answered by AI

Is enrollment still open for this investigation?

"According to the data hosted on clinicaltrials.gov, this trial is actively searching for participants and was initially posted on July 19th 2018 with its most recent update being August 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Ketorolac on Post Adenotonsillectomy Pain

Laura Gilbertson 2018. "Effect of Ketorolac on Post Adenotonsillectomy Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03467750.