Opioid-Free Anesthetic for Tonsillectomy

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04528173

Collaborator

University of Pennsylvania (Other), University of Tennessee Health Science Center (Other)

550

Enrollment

Locations

Arms

41.3

Anticipated Duration (Months)

275

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Opioid Use Tonsillitis Sleep Disorder Surgery	Drug: Ketorolac Drug: Dexmedetomidine Drug: Morphine Drug: Fentanyl	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The unblinded members are the treating anesthesiologist for the case, staff who randomize, and collect and enter intra-op medications into electronic data capture (EDC). Blinded members include the subject/family members, the surgeon, staff who perform post-op assessment, physician investigator who perform any adverse event/serious adverse event (AE/SAE) assessments, statistician and data safety monitoring board (DSMB).

Primary Purpose:

Treatment

Official Title:

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

Actual Study Start Date :

Jul 22, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Traditional Care Group (TCG)

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

Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Drug: Fentanyl

Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Experimental: Opioid-Free Group (OFG)

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

Drug: Ketorolac

Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.

Other Names:

Toradol

Drug: Dexmedetomidine

Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.

Other Names:

Precedex

Outcome Measures

Primary Outcome Measures

Median Maximum Pain Score [up to 30 minutes]
Median Maximum Pain Score by investigational group in the recovery room, calculated by the blinded observer 15 and 30 minutes after awakening.

Secondary Outcome Measures

Frequency of 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.
Frequency of readmission and of seeking unplanned medical attention (phone calls, office visits, ED visits) [up to 2 years]
Chart review and questionnaires for readmission and medical reattendance, including calls to physician
Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds) [up to 2 years]
Collected in recovery room and chart review
Percentage of patients receiving rescue opioids [up to 2 years]
Questionnaires and chart review
Family satisfaction with patient recovery based on seven-point Likert score [up to post-op day 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", "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.
Bleeding prevalence [up to 2 years]
Follow-up questionnaires and chart review

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
2	University of Tennessee Health Science Center; St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105

Sponsors and Collaborators

Children's Hospital of Philadelphia
University of Pennsylvania
University of Tennessee Health Science Center

Investigators

Principal Investigator: Tori Sutherland, MD,MPH, Children's Hospital of Philadelphia
Principal Investigator: Anthony Sheyn, MD, FACS, University of Tennessee Health Science Center