Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remifentanil+Morphine

Morphine(M) Remifentanil+Morphine(MR)

Group Type ACTIVE_COMPARATOR

Remifentanil+morphine

Intervention Type DRUG

Morphine, Remifentanil+Morphine

IV morphine PCA

IV remifentanil+morphine PCA

Group Type ACTIVE_COMPARATOR

Remifentanil+morphine

Intervention Type DRUG

Morphine, Remifentanil+Morphine

Interventions

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Remifentanil+morphine

Morphine, Remifentanil+Morphine

Intervention Type DRUG

Other Intervention Names

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Morphine Group (M) Remifentanil+Morphine Group (MR)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No