Opioid-Free Anesthetic for Tonsillectomy

Study Overview
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Brief Summary
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Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic

Detailed Description
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Objectives: Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy. Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy. Study Design: Prospective, randomized, multi-center trial study Study Interventions and Measures: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.

Official Title
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Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

Conditions
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Anesthesia, Opioid Use, Tonsillitis, Sleep Disorder, Surgery

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Dexmedetomidine
* Drug: Morphine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 2 to 18 years. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system Girls after menarche must have a negative pregnancy test. Scheduled tonsillectomy or tonsillectomy combined with adenoidectomy and/or ear tube placement at the Children's Hospital of Philadelphia (CHOP) main or ambulatory surgical centers. Parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria: Current (Within the last 30 days) opioid use for pain control High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement History of drug abuse, chronic pain, bleeding disorder Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated Significant congenital disorders, medication allergies or comorbidities, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease and use of medications that would increase risk of bleeding or bradycardia. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities) History of hypersensitivity to NSAIDs Patients with asthma, including patients who have experienced aspirin- or NSAID-sensitive asthma or a history of exacerbation when aspirin or NSAIDs are administered (e.g. bronchospasm, urticaria, etc.) Subjects receiving medications that could impact metabolism of either study drug should also be excluded Trisomy 21 diagnosis Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Patients on a Ketogenic diet Parents or subjects who do not speak English

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Care Group (TCG)<br>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. | Drug: Morphine<br>* Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.<br>Drug: Fentanyl<br>* Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.<br>|
| Experimental: Opioid-Free Group (OFG)<br>Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. | Drug: Ketorolac<br>* Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.<br>* Other names: Toradol;Drug: Dexmedetomidine<br>* Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Maximum Pain Score | Median Maximum Pain Score by investigational group in the recovery room, calculated by the blinded observer 15 and 30 minutes after awakening. | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of nausea, vomiting, pruritis | Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30. | up to post-op day 30 | 
| Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits) | Chart review and questionnaires for readmission and medical reattendance, including calls to physician | up to 2 years | 
| Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds) | Collected in recovery room and chart review | up to 2 years | 
| Percentage of patients receiving rescue opioids | Questionnaires and chart review | up to 2 years | 
| Family satisfaction with patient recovery based on seven-point Likert score | Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: I am satisfied with my child's recovery, and I am satisfied with my child's pain control at home. They will choose from the following options: Strongly agree = 1, Agree = 2, More or Less agree = 3, Undecided = 4, More or Less disagree = 5, Disagree = 6, Strongly Disagree =7. Minimum score is 1, Max is 7. Higher scores indicate worse outcomes. | up to post-op day 30 | 
| Bleeding prevalence | Follow-up questionnaires and chart review | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Opioid-Free, Ketorolac, Dexmedetomidine, Acute postoperative pain relief, Opioid, Morphine, Fentanyl