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Completed

NCT Number: NCT03529032

Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • 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.
  • german speaking patients

Exclusion criteria

  • patients including other studies
  • pregnant
  • breast feeding
  • patients in methadone substitution therapy
  • dependent drug user
  • patients with BMI greater than 36kg/m2
  • patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L
  • patients with liver insufficiency or failure
  • alcoholics
  • patients with acute heard attack

Treatment and study plan

Methadone

Drug

methadone for control postoperative pain

Primary outcomes

  1. Difference of postoperative morphine consumption

    Time frame: first 48 hours postoperatively

    Difference in milligrams of morphine used as rescue by patient controlled analgesia pump

Secondary outcomes

  1. Difference in pain scores, using the Numeric Rating Scale

    Time frame: first 72 hours postoperatively

    Difference in pain scores in rest and motion at 0,6,12,24,36,48,72 hours postoperative.

Sponsors and collaborators

Lead sponsor

Kantonsspital Baden

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2018
First posted
May 18, 2018
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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