Clinical trial NCT05445856: Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy
Official title: Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative pain
Methadone
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: On arrival at the post-anesthesia care unit
measure: Opioid consumption
timeFrame: First 5 postoperative days
Secondary outcomes:
measure: Postoperative pain
timeFrame: 1, 2, 3, 5 and 7 days after surgery
measure: Opioid consumption
timeFrame: 1 and 7 days after surgery
measure: Postoperative nausea and vomiting (none, mild, moderate, severe)
timeFrame: 1, 2 and 3 days after surgery
measure: Sedation
timeFrame: 4 hours after surgery
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Department of Anaesthesiology and Intensive Care
Study officials:
affiliation: Aarhus University Hospital, Department of Anesthesia and Intensive Care
name: Lone Nikolajsen, PhD, DMSc
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.