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Analgesic Efficacy, Safety an...

Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

NCT ID: NCT00508495

Last Updated: 2011-08-11

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

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test drug

Group Type EXPERIMENTAL

Paracetamol 1% solution

Intervention Type DRUG

Four 100 mL, 15 min IV infusions at six hour intervals

Reference drug

Group Type ACTIVE_COMPARATOR

Paracetamol (acetaminophen)

Intervention Type DRUG

Four 100 mL, 15 min IV infusions at six hour intervals

Placebo

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type DRUG

Four 100 mL, 15 min IV infusions at six hour intervals

Interventions

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Paracetamol (acetaminophen)

Four 100 mL, 15 min IV infusions at six hour intervals

Intervention Type DRUG

Paracetamol 1% solution

Four 100 mL, 15 min IV infusions at six hour intervals

Intervention Type DRUG

0.9% sodium chloride solution

Four 100 mL, 15 min IV infusions at six hour intervals

Intervention Type DRUG

Other Intervention Names

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Perfalgan Normal saline solution

Eligibility Criteria

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Inclusion Criteria

* ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
* Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.

Exclusion Criteria

* Another acute or chronic painful physical condition
* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
* Inability to use and understand Visual Analog Scale and Verbal Rating Score

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MDS Pharma Services

INDUSTRY

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Baxter Deutschland GmbH

Principal Investigators

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Keyvan Tadjalli Mehr, MD, MSc

Role: STUDY_DIRECTOR

Baxter Deutschland GmbH

Locations

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Réthy Pál Kórház-Rendelőintézet

Békéscsaba, , Hungary

Site Status

Semmelweis Egyetem Ortopédiai Klinika

Budapest, , Hungary

Site Status

Esztergom Város Önkormányzat Vaszary Kolos Kórháza

Esztergom, , Hungary

Site Status

Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Site Status

Bács-Kiskun Megyei Önkormányzat Kórháza

Kecskemét, , Hungary

Site Status

SZTE ÁOK Ortopédiai Klinika

Szeged, , Hungary

Site Status

Tolna Megyei Önkormányzat Balassa János Kórháza

Szekszárd, , Hungary

Site Status

Fejér Megyei Szent György Kórház

Székesfehérvár, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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EudraCT 2006-004075-36

Identifier Type: -

Identifier Source: secondary_id

R-01270-A016

Identifier Type: -

Identifier Source: org_study_id

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