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

NCT ID: NCT00665262

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-17

Study Completion Date

2011-08-12

Brief Summary

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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

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Conditions

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Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

comibined use of tramacet and naloxone infusion perioperatively

Group Type EXPERIMENTAL

tramacet

Intervention Type DRUG

2 tablets every 6 hours for 5 days

Interventions

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tramacet

2 tablets every 6 hours for 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ngozi Imasogie, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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St. Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12177

Identifier Type: OTHER

Identifier Source: secondary_id

R-06-159

Identifier Type: -

Identifier Source: org_study_id

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