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

December 4, 2023 updated by: University of Aarhus

Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Randers, Denmark
        • Recruiting
        • Department of Anaesthesiology and Intensive care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone
Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively
Drug: Methadone
Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
Active Comparator: Fentanyl
Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively
Drug: Fentanyl
Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: On arrival at the post-anesthesia care unit
Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)
On arrival at the post-anesthesia care unit
Opioid consumption
Time Frame: First 5 postoperative days
Cumulative postoperative opioid consumption in morphine equivalents
First 5 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 1, 2, 3, 5 and 7 days after surgery
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
Time Frame: 1 and 7 days after surgery
Cumulative postoperative opioid consumption in morphine equivalents
1 and 7 days after surgery
Postoperative nausea and vomiting (none, mild, moderate, severe)
Time Frame: 1, 2 and 3 days after surgery
Nausea and/or vomiting (PONV), proportion of patients with none or mild PONV
1, 2 and 3 days after surgery
Sedation
Time Frame: 4 hours after surgery
Level of sedation (Ramsay Scale (1-4)), proportion of patients being co-operative, oriented and tranquil
4 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Lone Nikolajsen, PhD, DMSc, Aarhus University Hospital, Department of Anesthesia and Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-002496-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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