Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy

Postoperative Pain Clinical Trial

— METATONS  

Official title:

Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445856
• Other study ID #: 2022-002496-11
• Status: Recruiting
• Phase: Phase 4
• Start date: November 28, 2022
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: Michael Bøndergaard, MD
• Phone: 004578420510
• Email: michael.vinther[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial evaluating the efficacy and safety of single-shot intraoperative methadone for postoperative pain in patients undergoing tonsillectomy. Fentanyl is used as an active comparator

Description:

This study is an investigator-initiated, prospective, randomised controlled trial with two arms: an intervention arm (methadone) and a control arm (fentanyl). Patients scheduled for tonsillectomy at Randers Regional Hospital, Denmark, will be approached for study participation. Patients are randomised in a 1:1 ratio in blocks of varying sizes (between 4 and 8) to receive either intraoperative methadone or fentanyl. The randomisation assignment will be handled by the hospital pharmacy using a web-based central randomisation procedure (www.sealedenvelope.com). The study drug will be prepared by the hospital pharmacy at Aarhus University Hospital and delivered as kits with identical appearance, marked with the randomization number (1-130). On the day of surgery, a kit will be opened and a 10 ml syringe with study drug (methadone 2 mg/ml or fentanyl 30 microgram/ml or ) will prepared by a health care professional (nurse or medical doctor not involved in the study or the treatment of patients). Once prepared, the blinded study drug will be given to and handled by one of the research team members and administered after induction of anesthesia and prior to surgery The dose of the study drug will be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg / 3 μg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (women: height (cm) - 105. Men: height (cm) - 100)) after induction of anaesthesia and before the start of surgery. Postoperative data will be obtained by reviewing hospital records, by interview and electronic questionnaires sent by email.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients (=18 years) scheduled for elective tonsillectomy

Exclusion Criteria:

• American Society of Anaesthesiologists (ASA) physical status IV or V
• Allergy to study drugs
• Daily use of opioids 7 days prior to surgery
• Inability to provide informed consent
• Severe respiratory insufficiency
• Heart failure
• Acute alcohol intoxication/delirium tremens
• Increased intracranial pressure
• Acute liver disease
• Liver insufficiency
• Kidney insufficiency
• Treatment with rifampicin
• Treatment with any drug prolonging the QT-interval
• Pregnancy (every female not using contraceptives will be screened with urine human choriogonadotropin)
• Breastfeeding

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Methadone
Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
• Fentanyl
Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology and Intensive Care	Randers

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24. — View Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633. — View Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609. — View Citation

Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)	On arrival at the post-anesthesia care unit
Primary	Opioid consumption	Cumulative postoperative opioid consumption in morphine equivalents	First 5 postoperative days
Secondary	Postoperative pain	Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)	1, 2, 3, 5 and 7 days after surgery
Secondary	Opioid consumption	Cumulative postoperative opioid consumption in morphine equivalents	1 and 7 days after surgery
Secondary	Postoperative nausea and vomiting (none, mild, moderate, severe)	Nausea and/or vomiting (PONV), proportion of patients with none or mild PONV	1, 2 and 3 days after surgery
Secondary	Sedation	Level of sedation (Ramsay Scale (1-4)), proportion of patients being co-operative, oriented and tranquil	4 hours after surgery