Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy
NCT ID: NCT05445856
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2022-11-28
2024-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methadone
Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively
Methadone
Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
Fentanyl
Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively
Fentanyl
Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
100 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lone Nikolajsen, PhD, DMSc
Role: STUDY_CHAIR
Aarhus University Hospital, Department of Anesthesia and Intensive Care
Locations
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Department of Anaesthesiology and Intensive Care
Randers, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Michael Bøndergaard, MD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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2022-002496-11
Identifier Type: -
Identifier Source: org_study_id