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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Experimental | Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively |
|
| Fentanyl | Active Comparator | Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes) | On arrival at the post-anesthesia care unit |
| Opioid consumption | Cumulative postoperative opioid consumption in morphine equivalents | First 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioid consumption | Cumulative postoperative opioid consumption in morphine equivalents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Bøndergaard, MD | Contact | 004578420510 | michael.vinther@gmail.com | |
| Kristian Friesgaard, MD, PhD | Contact | 00457842332 | k.friesgaard@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Lone Nikolajsen, PhD, DMSc | Aarhus University Hospital, Department of Anesthesia and Intensive Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care | Recruiting | Randers | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28418966 | Background | 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. | |
| 25837528 |
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IPD will be shared upon reasonable request
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Fentanyl | Drug | Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery |
|
| 1 and 7 days after surgery |
| 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 |
| Sedation | Level of sedation (Ramsay Scale (1-4)), proportion of patients being co-operative, oriented and tranquil | 4 hours after surgery |
| 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. |
| 20418538 | Background | 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. |
| 22063370 | Background | 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. |
| 40502985 | Derived | Bondergaard M, Uhrbrand PG, Karaca T, Rhode M, Kjaergaard T, Svendsen RT, Klug TE, Nikolajsen L, Friesgaard KD. Intraoperative methadone for postoperative pain in adult patients undergoing tonsillectomy-a randomised controlled trial. BJA Open. 2025 May 26;14:100418. doi: 10.1016/j.bjao.2025.100418. eCollection 2025 Jun. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |