Post Operative Pain Control: Morphine vs Fentanyl

May 21, 2014 updated by: Francesca Bevilacqua, Catholic University of the Sacred Heart

Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University of the Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: data were recorded during the 24 post operative hours
data were recorded at 1,6,18 and 24 hours after surgery
data were recorded during the 24 post operative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic requirements
Time Frame: during the 24 hours after surgery
if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv
during the 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFN-6932-AS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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