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NCT02146638 Clinical Trial

Post Operative Pain Control: Morphine vs Fentanyl

Post Operative Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02146638
Other study ID # MFN-6932-AS
Secondary ID
Status Completed
Phase N/A
First received January 10, 2013
Last updated May 21, 2014
Start date April 2012
Est. completion date September 2012

Study information
Verified date May 2014
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics CommitteeItaly: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 59 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Morphine

• Fentanyl

Locations
Country Name City State
Italy catholic University of the sacred Heart Rome

Sponsors (1)
Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain scores data were recorded at 1,6,18 and 24 hours after surgery data were recorded during the 24 post operative hours No
Secondary analgesic requirements if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv during the 24 hours after surgery No
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