NCT03529032

Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Kantonsspital Baden · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.

Detailed description

Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Methadone	methadone for control postoperative pain

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-07-01
• Completion: 2018-05-01
• First posted: 2018-05-18
• Last updated: 2018-07-03

Locations

1 site across 1 country: Switzerland