Methadone for pain control after tonsillectomy

Phase 1

• Conditions: Same-day tonsillectomy; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2022-002496-11-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-01
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients (=15 years) scheduled for elective tonsillectomy are screened for inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
•Known severe respiratory insufficiency
•Known heart failure
•Acute alcohol intoxication/delirium tremens
•Known increased intracranial pressure
•Acute liver disease
•Known liver insufficiency
•Known kidney insufficiency
•Treatment with rifampicin
•Treatment with any drug prolonging the QT-interval
•Pregnancy (every fertile female not using contraceptives will be screened with urine human choriogonadotropin)
•Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for tonsillectomy. A single dose of intravenous intraoperative fentanyl will be used as an active comparator.;Secondary Objective: Not applicable<br>;Primary end point(s): •Pain intensity (NRS, 0-10) at swallowing on arrival at the post-anesthesia care unit (PACU)<br><br>•Total postoperative opioid consumption from extubation to 5 days after surgery<br><br>;Timepoint(s) of evaluation of this end point: - on arrival at the post-anesthesia care unit (PACU)<br>- 5 days after extubation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Pain intensity (NRS, 0-10) at swallowing 1,2,3, 5 and 7 days after surgery<br>•Opioid consumption at 24 hours and 7 days after extubation (total postoperative opioid consumption from extubation to 24 hours and 7 days after surgery)<br>•Patient satisfaction (NRS, 0-10) with pain management at 24 hours and 7 days after extubation<br>•Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) 1, 2 and 3 days after extubation<br>•Time from arrival to discharge from PACU and hospital (hours and minutes).<br>•Level of sedation at observation at the PACU (Ramsay Sedation Scale [18] at 4 hours after extubation)<br>•Any adverse events during observation at the PACU:<br>oHypoventilation (respiratory rate < 10/minutes) <br>oHypoxemia (peripheral oxygen saturation < 90%)<br>;Timepoint(s) of evaluation of this end point: - 4 hours after extubation <br>- 1, 2, 3, 5 and 7 days after extubation