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Opioid-Free Anesthesia for Tonsillectomy

Phase 4

Recruiting

Led By Tori Sutherland, MD,MPH

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will compare two types of anesthesia for tonsillectomy surgery, one with opioids and one without, to see if the opioid-free option is just as good.

Who is the study for?

This trial is for children aged 2-18 scheduled for tonsillectomy at CHOP, without recent opioid use or high bleeding risk. They must not have NSAID allergies, asthma related to NSAIDs, severe congenital disorders, drug abuse history, chronic pain conditions, or significant organ dysfunction.Check my eligibility

What is being tested?

The study tests if an opioid-free anesthetic (using drugs like Ketorolac and Dexmedetomidine) is as effective as standard anesthesia with opioids (like Fentanyl and Morphine) in children undergoing tonsillectomy.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the medications used; breathing difficulties; increased risk of bleeding with Ketorolac; and potential heart rate or rhythm issues with Dexmedetomidine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median Maximum Pain Score

Secondary outcome measures

Bleeding prevalence

Family satisfaction with patient recovery based on seven-point Likert score

Frequency of nausea, vomiting, pruritis

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid-Free Group (OFG)Experimental Treatment2 Interventions

Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.

Group II: Traditional Care Group (TCG)Active Control2 Interventions

Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac

FDA approved

Dexmedetomidine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Tennessee Health Science CenterOTHER

48 Previous Clinical Trials

24,554 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

707 Previous Clinical Trials

8,580,741 Total Patients Enrolled

University of PennsylvaniaOTHER

2,000 Previous Clinical Trials

42,879,538 Total Patients Enrolled

Media Library

Opioid-Free Anesthetic (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04528173 — Phase 4

Tonsillitis Research Study Groups: Opioid-Free Group (OFG), Traditional Care Group (TCG)

Tonsillitis Clinical Trial 2023: Opioid-Free Anesthetic Highlights & Side Effects. Trial Name: NCT04528173 — Phase 4

Opioid-Free Anesthetic (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04528173 — Phase 4

Frequently Asked Questions

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

Is enrollment open to minors for this medical experiment?

"This particular medical research is open to minors between 2 and 18 years of age. There are 159 trials specifically for people in this demographic, while 633 studies concentrate on individuals over 65."

Answered by AI

Are there other examinations that have been conducted concerning Ketorolac?

"Currently, there are 220 ongoing studies on ketorolac and 49 of them have entered Phase 3. With 425 recruiting sites across the United States, many of which in Boston Massachusetts, this medication is being heavily researched."

Answered by AI

To what degree is Ketorolac a secure medication for individuals?

"The safety of Ketorolac has been clinically validated, thus it earned a score of 3."

Answered by AI

How many participants is the maximum capacity for this clinical experiment?

"Affirmative, clinicaltrials.gov reveals that the trial is actively seeking participants. Initially posted on July 22nd 2020 and modified as recently as August 29th 2022, this medical research requires 550 individuals to be enrolled from two separate facilities."

Answered by AI

Is eligibility for this trial open at the present time?

"Correct. Data held on clinicaltrials.gov suggests that recruitment for this trial, which was originally published on July 22nd 2020, is currently ongoing. Approximately 550 people need to be recruited from 2 distinct medical facilities."

Answered by AI

For what medical conditions is Ketorolac commonly prescribed?

"Ketorolac is generally prescribed to reduce the effects of general anesthesia. In addition, it's also utilized in cases such as miosis disorder and intraocular lens replacement."

Answered by AI

Could I fulfill the criteria for this experimental research?

"This medical research is seeking 550 pediatric patients between the ages of two and eighteen suffering from tonsillitis. To be eligible, participants must meet these conditions: Male or female with a maximum American Society of Anesthesiologists (ASA) physical classification score 3; post-menarche girls must present a negative pregnancy test result; undergo scheduled tonsillectomy/tonsillectomy in combination with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP)'s main or ambulatory surgical centers."

Answered by AI