Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy

NCT05445856 | Unknown Phase 4

• 1 other identifier: 2022-002496-11
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

Postoperative pain; Methadone

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Postoperative pain

  1, 2, 3, 5 and 7 days after surgery

• Opioid consumption

  1 and 7 days after surgery

• Postoperative nausea and vomiting (none, mild, moderate, severe)

  1, 2 and 3 days after surgery

• Sedation

  4 hours after surgery

Study Arms (2)

Methadone

EXPERIMENTAL

Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively

Drug: Methadone

Fentanyl

ACTIVE COMPARATOR

Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively

Drug: Fentanyl

Interventions

Methadone DRUG

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

Methadone

Fentanyl DRUG

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

Fentanyl

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care

Randers, Denmark

RECRUITING

Related Publications (5)

• 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.

  PMID: 28418966 BACKGROUND

• 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.

  PMID: 25837528 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.

  PMID: 20418538 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.

  PMID: 22063370 BACKGROUND

• 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.

  PMID: 40502985 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lone Nikolajsen, PhD, DMSc

  Aarhus University Hospital, Department of Anesthesia and Intensive Care

  STUDY CHAIR

Central Study Contacts

Michael Bøndergaard, MD

CONTACT

004578420510; michael.vinther@gmail.com

Kristian Friesgaard, MD, PhD

CONTACT

00457842332; k.friesgaard@me.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: November 28, 2022
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

DK (1)