Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

NCT ID: NCT00344045

Last Updated: 2015-11-04

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-02-29

Brief Summary

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The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours

Interventions

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Paracetamol

IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours

Intervention Type DRUG

Placebo

IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours

Intervention Type DRUG

Other Intervention Names

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Perfalgan

Eligibility Criteria

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Inclusion Criteria

* Spinal anesth
* BMI 10-35
* No pain conditions/concom med may alter pain quantif.

Exclusion Criteria

* Other add. surgery
* Liver/Renal function altered
* coagulation alterations
* Respir / Cardiac insufficiency
* Agents affecting microsomal syst
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Alcorcón, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Vizcaya, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CN145-010

Identifier Type: -

Identifier Source: org_study_id

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