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Post Operative Pain Control: Morphine vs Fentanyl

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT02146638
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5
Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Morphine

Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.

Drug: Morphine
Experimental: Fentanyl

Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.

Drug: Fentanyl
Other Names:
  • Fentanest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain scores [data were recorded during the 24 post operative hours]

      data were recorded at 1,6,18 and 24 hours after surgery

    Secondary Outcome Measures

    1. analgesic requirements [during the 24 hours after surgery]

      if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 59 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA 1 or 2 patients

    • undergoing major gynaecological surgery

    Exclusion Criteria:

    • age > 60 years

    • obesity (BMI>30 Kg/m2)

    • cardiac and respiratory diseases

    • renal impairment

    • liver disorders

    • allergies to any drug used in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 catholic University of the sacred Heart Rome Italy 00168

    Sponsors and Collaborators

    • Catholic University of the Sacred Heart

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesca Bevilacqua, medical doctor, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT02146638
    Other Study ID Numbers:
    • MFN-6932-AS
    First Posted:
    May 26, 2014
    Last Update Posted:
    May 26, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Francesca Bevilacqua, medical doctor, Catholic University of the Sacred Heart
    post operative analgesia, morphine, fentanyl
    Additional relevant MeSH terms:
    Pain, Postoperative
    Fentanyl
    Morphine

    Study Results

    No Results Posted as of May 26, 2014