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Intravenous Remifentanil Plus Morphine or Morphine Alone for Postthoracotomy Pain

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ClinicalTrials.gov Identifier: NCT01830296
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Hakki Unlugenc, Cukurova University

Brief 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

Condition or disease Intervention/treatment Phase
Pain Drug: Remifentanil+morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE
Study Start Date : May 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil+Morphine
Morphine(M) Remifentanil+Morphine(MR)
Drug: Remifentanil+morphine
Morphine, Remifentanil+Morphine
Other Names:
  • Morphine Group (M)
  • Remifentanil+Morphine Group (MR)

Active Comparator: IV morphine PCA
IV remifentanil+morphine PCA
Drug: Remifentanil+morphine
Morphine, Remifentanil+Morphine
Other Names:
  • Morphine Group (M)
  • Remifentanil+Morphine Group (MR)




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830296


Locations
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Turkey
Hakkı Unlugenc
Adana, Turkey, 01330
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: Mediha Turktan, Assist Prof Cukurova University, Department of Anaesthesiology
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Responsible Party: Hakki Unlugenc, Prof Dr., Cukurova University
ClinicalTrials.gov Identifier: NCT01830296    
Other Study ID Numbers: MDHTRKTN13
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Keywords provided by Hakki Unlugenc, Cukurova University:
Postthoracotomy pain,
patient controlled analgesia,
remifentanil and
morphine.
Additional relevant MeSH terms:
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Morphine
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents