NCT02146638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

January 10, 2013

Last Update Submit

May 21, 2014

Conditions

Post Operative Analgesia

Keywords

post operative analgesia, morphine, fentanyl

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • analgesic requirements

    during the 24 hours after surgery

Study Arms (2)

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

MorphineDRUG
Morphine
FentanylDRUG
Also known as: Fentanest
Fentanyl

Eligibility Criteria

Age35 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 or 2 patients
  • undergoing major gynaecological surgery

You may not qualify if:

  • age \> 60 years
  • obesity (BMI\>30 Kg/m2)
  • cardiac and respiratory diseases
  • renal impairment
  • liver disorders
  • allergies to any drug used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

catholic University of the sacred Heart

Rome, Rome, 00168, Italy

Location

MeSH Terms

Interventions

MorphineFentanyl

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 10, 2013

First Posted

May 26, 2014

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

IT(1)