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Completed

NCT Number: NCT01830296

Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hakkı Unlugenc

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Remifentanil+morphine

Drug

Morphine, Remifentanil+Morphine

Other names: Morphine Group (M), Remifentanil+Morphine Group (MR)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2013
Registry last updated
Apr 12, 2013

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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