Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

Pain Clinical Trial

Official title:

COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830296
• Other study ID #: MDHTRKTN13
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2013
• Last updated: April 10, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Remifentanil+morphine
Morphine, Remifentanil+Morphine

Locations

Country	Name	City	State
Turkey	Hakki Unlugenc	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE	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.	Two years	No