Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

Overview

Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Full Title of Study: “COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2012

Detailed Description

Methods; Sixty patients were allocated randomly to receive an intravenous patient-controlled analgesia with morphine alone (M), or morphine plus remifentanil (MR), in a double-blind manner. Postoperatively patients were allowed to use bolus doses of morphine (0.2 mg kg-1) or morphine (0.2 mg kg-1) plus remifentanil (0.2 µg kg-1) mixture every 10 min without a background infusion. Pain, discomfort, sedation scores, total and bolus patient-controlled morphine consumption, rescue analgesic requirement and side-effects were recorded for up to 24 h after the start of patient-controlled analgesia.

Interventions

  • Drug: Remifentanil+morphine
    • Morphine, Remifentanil+Morphine

Arms, Groups and Cohorts

  • Active Comparator: Remifentanil+Morphine
    • Morphine(M) Remifentanil+Morphine(MR)
  • Active Comparator: IV morphine PCA
    • IV remifentanil+morphine PCA

Clinical Trial Outcome Measures

Primary Measures

  • COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE
    • Time Frame: Two years
    • As aim of this study was to evaluate the effects of remifentanil addition to morphine for i.v. PCA on analgesic consumption, the primary endpoint was defined as morphine consumption at 24 hour.

Participating in This Clinical Trial

Inclusion Criteria

  • 60 ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study Exclusion Criteria:

  • severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for > 3 months), drug or alcohol abuse and contraindication to administration of PCA

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cukurova University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hakki Unlugenc, Prof Dr. – Cukurova University
  • Overall Official(s)
    • Mediha Turktan, Assist Prof, Study Director, Cukurova University, Department of Anaesthesiology

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