What side effects are associated with this type of intervention?

Common treatments for tonsillitis, particularly those avoiding opioids, include non-opioid analgesics like acetaminophen and ibuprofen, which can cause side effects such as gastrointestinal upset, liver toxicity (with acetaminophen), and renal issues (with ibuprofen). Antibiotics, often prescribed for bacterial tonsillitis, can lead to gastrointestinal disturbances, allergic reactions, and antibiotic resistance. Non-pharmacologic treatments, such as hydration and throat lozenges, generally have minimal side effects but may not be sufficient for severe cases. These treatments aim to manage pain and infection without the risks associated with opioid use, such as addiction and opioid-related side effects.

What prior FDA approvals exist?

FDA-approved treatments for tonsillitis primarily include antibiotics such as penicillin, amoxicillin, and cephalosporins, which target the bacterial cause of the infection. For pain management, non-opioid options like acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used. These treatments help manage symptoms without the risk of opioid-related side effects and potential for addiction.

What other types of research exist?

Promising alternatives to opioid-free anesthetic for tonsillitis patients include the use of neuraxial anesthesia techniques such as epidural or spinal anesthesia, which have been associated with reduced perioperative morbidity. Additionally, regional anesthesia techniques like transversus abdominis plane (TAP) blocks and rectus sheath blocks are effective in managing postoperative pain without the use of opioids. Non-invasive ventilation during surgery under neuraxial anesthesia can also be beneficial. These methods help in reducing the risk of opioid-related side effects and potential for addiction.

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Other

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

All Individual Drugs Already Approved

Pivotal Trial

Approved for 10 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing if a type of anesthesia that doesn't use strong painkillers can manage pain just as well as traditional methods during and after tonsil removal surgery. It focuses on patients undergoing this surgery to see if they can avoid the side effects of opioids.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median Maximum Pain Score

Secondary study objectives

Bleeding prevalence

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

Frequency of nausea, vomiting, pruritis

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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

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.