The Effect of the Combined Use of Naloxone and Tramacet o... | NCT00665262

Studies
The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly

NCT00665262

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Aug 28, 2017Actual

Enrollment

10Actual

Phase

Phase 4

Conditions

Arthroplasty

Interventions

tramacet

Countries

Canada

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

ID	Type	Description	Link
12177	Other Identifier	REB

Status Module

Record Verification Date

Aug 2017

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

Dec 17, 2007Actual

Primary Completion Date

Nov 30, 2010Actual

Completion Date

Aug 12, 2011Actual

First Submitted Date

Apr 18, 2008

First Submission Date that Met QC Criteria

Apr 18, 2008

First Posted Date

Apr 23, 2008Estimated

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

Aug 25, 2017

Last Update Posted Date

Aug 28, 2017Actual

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

Ten patients 70 years and older having elective total hip/knee replacement surgery will be recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia. Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length of stay.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	comibined use of tramacet and naloxone infusion perioperatively	Drug: tramacet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tramacet	Drug	2 tablets every 6 hours for 5 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
opoid use post knee/hip arthroplasty		post-op period

Secondary Outcomes

Measure	Description	Time Frame
incidence of visual analogue scale scores greater than 4		post-op period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 70 years or older able to give consent able to communicate in English having elective hip/knee arthroplasty ASA physical status 1-3

Exclusion Criteria:

allergies to any of the following: naloxone, tramacet, NSAIDs, sulpha, or local anesthesic contraindication to spinal anesthesia contraindication to use of tramacet or celebrex ASA physical status4 chronic opiod use chronic pain syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ngozi Imasogie, MD	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Health Care		London	Ontario	N6A 4V2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided