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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
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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Tonsillitis include non-opioid analgesics like acetaminophen and NSAIDs, which reduce inflammation and block pain signals, and corticosteroids, which help to reduce inflammation and swelling. Antibiotics are also used to treat bacterial infections.
Focusing on non-opioid treatments is important for Tonsillitis patients to avoid the side effects and potential for addiction associated with opioids, ensuring safer and effective pain management.
Sustaining standardized opioid prescribing practices after pediatric tonsillectomy.
Sustaining standardized opioid prescribing practices after pediatric tonsillectomy.
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
710 Previous Clinical Trials
8,588,414 Total Patients Enrolled
University of PennsylvaniaOTHER
2,016 Previous Clinical Trials
42,873,546 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used opioid pain medication in the last 30 days.You have a high risk of bleeding after surgery due to a bleeding disorder or poor blood clotting.You have asthma and have had bad reactions to aspirin or NSAIDs in the past.You have had a bad reaction to NSAIDs before.You have been diagnosed with trisomy 21.You have a chronic illness like sickle cell disease that may require treatment with opioids.Boys and girls between 2 and 18 years oldYou have a history of using drugs, long-lasting pain, or a bleeding disorder.You have a history of liver or kidney problems, low platelet count, or low red blood cell count.You have serious health problems or allergies to certain medications, especially related to heart conditions or bleeding risks.You are following a ketogenic diet.You have an American Society of Anesthesiologists (ASA) physical status score of 3 or lower.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid-Free Group (OFG)
- Group 2: Traditional Care Group (TCG)
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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