Opioid-Free Anesthetic for Tonsillectomy

Surgery Clinical Trial

Official title:

Opioid-Free Versus Transitional Anesthetic With Opioids From Tonsillectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528173
• Other study ID #: 19-016618
• Status: Recruiting
• Phase: Phase 4
• Start date: July 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: Tori N Sutherland, MD,MPH
• Phone: 267-426-2961
• Email: sutherlant[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Opioid Use
• Sleep Disorder
• Sleep Wake Disorders
• Surgery
• Tonsillitis

Intervention

Drug:
• Ketorolac
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
• Dexmedetomidine
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
• Morphine
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
• Fentanyl
Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center; St. Jude Children's Research Hospital	Memphis	Tennessee
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Pennsylvania, University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (34)

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Franz AM, Dahl JP, Huang H, Verma ST, Martin LD, Martin LD, Low DK. The development of an opioid sparing anesthesia protocol for pediatric ambulatory tonsillectomy and adenotonsillectomy surgery-A quality improvement project. Paediatr Anaesth. 2019 Jul;29 — View Citation

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Lee MS, Montague ML, Hussain SS. Post-tonsillectomy hemorrhage: cold versus hot dissection. Otolaryngol Head Neck Surg. 2004 Dec;131(6):833-6. doi: 10.1016/j.otohns.2004.08.008. — View Citation

Macario A, Lipman AG. Ketorolac in the era of cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs: a systematic review of efficacy, side effects, and regulatory issues. Pain Med. 2001 Dec;2(4):336-51. doi: 10.1046/j.1526-4637.2001.01043.x. — View Citation

Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226. — View Citation

Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477. — View Citation

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McClain K, Williams AM, Yaremchuk K. Ketorolac usage in tonsillectomy and uvulopalatopharyngoplasty patients. Laryngoscope. 2020 Apr;130(4):876-879. doi: 10.1002/lary.28077. Epub 2019 May 30. — View Citation

Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executi — View Citation

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Mowatt G, Cook JA, Fraser C, McKerrow WS, Burr JM. Systematic review of the safety of electrosurgery for tonsillectomy. Clin Otolaryngol. 2006 Apr;31(2):95-102. doi: 10.1111/j.1749-4486.2006.01162.x. — View Citation

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Mudd PA, Thottathil P, Giordano T, Wetmore RF, Elden L, Jawad AF, Ahumada L, Galvez JA. Association Between Ibuprofen Use and Severity of Surgically Managed Posttonsillectomy Hemorrhage. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):712-717. doi: 10. — View Citation

Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anes — View Citation

Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Frequency of non-artifactual percentage of oxygen saturation (SpO2)<90% (>30 seconds)	Collected in recovery room and chart review	up to 2 years
Secondary	Percentage of patients receiving rescue opioids	Questionnaires and chart review	up to 2 years
Secondary	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
Secondary	Bleeding prevalence	Follow-up questionnaires and chart review	up to 2 years

External Links

•   Buck, ML. Use of Intravenous Ketorolac for Postoperative Analgesia in Infants: Pediatric Pharmacotherapy, A Monthly Newsletter. . 2011
•   Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044). Center f
•   Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial.