Post Operative Pain Control: Morphine vs Fentanyl | NCT02146638

Studies
Post Operative Pain Control: Morphine vs Fentanyl

NCT02146638

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

May 26, 2014Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Post Operative Analgesia

Interventions

Morphine
Fentanyl

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2014

Last Update Posted Date

May 26, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesca Bevilacqua, medical doctor, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morphine	Active Comparator	Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.	Drug: Morphine
Fentanyl	Experimental	Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline.	Drug: Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morphine	Drug		Morphine
Fentanyl

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
catholic University of the sacred Heart		Rome	Rome	00168	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D005283	Fentanyl

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided