Postoperative Pain
Conditions
Keywords
Postoperative pain, Methadone
Brief summary
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
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.
Interventions
DRUGMethadone
Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
DRUGFentanyl
Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | On arrival at the post-anesthesia care unit | Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes) |
| Opioid consumption | First 5 postoperative days | Cumulative postoperative opioid consumption in morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 1, 2, 3, 5 and 7 days after surgery | Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes) |
| Opioid consumption | 1 and 7 days after surgery | Cumulative postoperative opioid consumption in morphine equivalents |
| Postoperative nausea and vomiting (none, mild, moderate, severe) | 1, 2 and 3 days after surgery | Nausea and/or vomiting (PONV), proportion of patients with none or mild PONV |
| Sedation | 4 hours after surgery | Level of sedation (Ramsay Scale (1-4)), proportion of patients being co-operative, oriented and tranquil |
Countries
Denmark
Contacts
Primary ContactMichael Bøndergaard, MD
Backup ContactKristian Friesgaard, MD, PhD
Outcome results
None listed