Opioid-Free Anesthetic for Tonsillectomy

Phase 4

Terminated

• Conditions: Tonsillitis; Opioid Use; Sleep Disorder; Surgery; Anesthesia
• Interventions: Drug: Ketorolac; Drug: Morphine; Drug: Fentanyl; Drug: Dexmedetomidine

• Registration Number: NCT04528173
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-22
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Primary Completion: 2023-08-22
• Study Completion: 2023-08-22
• Results First Submitted: 2024-07-03
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Males or females age 2 to 18 years.
2. American Society of Anesthesiologists {ASA) ≤ 3 physical classification system
3. Girls after menarche must have a negative pregnancy test.
4. 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.
5. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

1. Current (Within the last 30 days) opioid use for pain control
2. High risk for surgical site hemorrhage, determined by bleeding disorder diagnosis or evidence or poor hemostasis
3. Multiple scheduled surgeries at the same time other than adenoidectomy and/or ear tube placement
4. History of drug abuse, chronic pain, bleeding disorder
5. Chronic disease such as sickle cell disease for which treatment with opioids may be clinically indicated
6. 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.
7. History of hepatic dysfunction, renal dysfunction, thrombocytopenia, or anemia (including pre-surgery laboratory abnormalities)
8. History of hypersensitivity to NSAIDs
9. 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.)
10. Subjects receiving medications that could impact metabolism of either study drug should also be excluded
11. Trisomy 21 diagnosis
12. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
13. Patients on a Ketogenic diet
14. Parents or subjects who do not speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Care Group (TCG)	Fentanyl	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.
Opioid-Free Group (OFG)	Ketorolac	Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.
Traditional Care Group (TCG)	Morphine	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.
Opioid-Free Group (OFG)	Dexmedetomidine	Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac.

Primary Outcome Measures

Name	Time	Method
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score	up to 1 hour	Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes.; One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Nausea, Vomiting, Pruritis	up to post-op day 30	Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
Number of Participants Who Sought Unplanned Medical Attention	up to post-op day 30	Number of participants who were readmitted to the hospital and sought unplanned medical attention (phone calls, office visits, emergency department visits) by chart review and questionnaires for readmission and medical reattendance, including calls to physician
Number of Participants Who Were Readmitted to the the Hospital	Up to post-op day 30	Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician.
Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)	up to post-op day 30	Number of participants with non-artefactual percentage of oxygen saturation (SpO2) less than 90% for greater than 30 seconds). Collected in the recovery room and chart review
Number of Patients Receiving Rescue Opioids	up to post-op day 30	How many subjects received rescue opioids after surgery
Family Satisfaction With Patient Recovery Based on Five-point Likert Score	assessed at post-op days 1, 5, and 30	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", "Undecided = 3", "Disagree = 4", "Strongly Disagree =5." Minimum score is 1, Max is 5. Higher scores indicate worse outcomes. Data assessed at post-op days 1, 5, and 30 were averaged.
Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study	up to post-op day 30	Follow-up questionnaires administered on post-operative day 1, 5, ad 30 and chart review.; Question: Has your child had any bright red blood in their mouth? Answer options: Yes/No

Trial Locations

Locations (2)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Tennessee Health Science Center; St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States