Using methadone to manage pain after tonsil surgery
Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial
This study tests if giving methadone during tonsil surgery can help manage pain better than fentanyl for patients recovering from the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Randers) |
| Trial ID | NCT05445856 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of a single dose of methadone administered during surgery to manage postoperative pain in patients undergoing tonsillectomy. It is a randomized controlled trial comparing methadone to fentanyl, with patients randomly assigned to one of the two treatment arms. The study will take place at Randers Regional Hospital in Denmark, where the drugs will be prepared and administered by trained healthcare professionals. Data on postoperative pain levels and recovery will be collected to assess the outcomes of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective tonsillectomy.
Not a fit: Patients with severe health conditions, allergies to the study drugs, or those on opioids prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective pain management option for patients recovering from tonsillectomy.
How similar studies have performed: Previous studies have shown promising results with methadone for pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Randers
- Department of Anaesthesiology and Intensive Care — Randers, Denmark (Recruiting)
Study contacts
- Study coordinator: Michael Bøndergaard, MD
- Email: michael.vinther@gmail.com
- Phone: 004578420510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.