Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy (METATONS)

University of Aarhus

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Fentanyl; Drug: Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT05445856

2022-002496-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups

Methadone

Experimental group

Description:

Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively

Treatment:

Drug: Methadone

Fentanyl

Active Comparator group

Description:

Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively

Treatment:

Drug: Fentanyl