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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Paracetamol (acetaminophen)
Paracetamol 1% solution
0.9% sodium chloride solution
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pain, postoperative, replacement, total hip, total hip replacement, arthroplasty, replacement, hip

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweis Egyetem Ortopédiai Klinika
  • Réthy Pál Kórház-Rendelőintézet
  • Esztergom Város Önkormányzat Vaszary Kolos Kórháza
  • Petz Aladár Megyei Oktató Kórház
  • Bács-Kiskun Megyei Önkormányzat Kórháza
  • SZTE ÁOK Ortopédiai Klinika
  • Fejér Megyei Szent György Kórház
  • Tolna Megyei Önkormányzat Balassa János Kórháza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test drug

Reference drug

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Amount of PCA-administered morphine consumed during first six hours of study drug treatment

Secondary Outcome Measures

Full Information

First Posted
July 26, 2007
Last Updated
August 10, 2011
Sponsor
Baxter Healthcare Corporation
Collaborators
MDS Pharma Services
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1. Study Identification

Unique Protocol Identification Number
NCT00508495
Brief Title
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Official Title
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
MDS Pharma Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain, postoperative, replacement, total hip, total hip replacement, arthroplasty, replacement, hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test drug
Arm Type
Experimental
Arm Title
Reference drug
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol (acetaminophen)
Other Intervention Name(s)
Perfalgan
Intervention Description
Four 100 mL, 15 min IV infusions at six hour intervals
Intervention Type
Drug
Intervention Name(s)
Paracetamol 1% solution
Intervention Description
Four 100 mL, 15 min IV infusions at six hour intervals
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride solution
Other Intervention Name(s)
Normal saline solution
Intervention Description
Four 100 mL, 15 min IV infusions at six hour intervals
Primary Outcome Measure Information:
Title
Amount of PCA-administered morphine consumed during first six hours of study drug treatment
Time Frame
6 hours from first (of four) study drug doses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Tadjalli Mehr, MD, MSc
Organizational Affiliation
Baxter Deutschland GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis Egyetem Ortopédiai Klinika
City
Budapest
Country
Hungary
Facility Name
Réthy Pál Kórház-Rendelőintézet
City
Békéscsaba
Country
Hungary
Facility Name
Esztergom Város Önkormányzat Vaszary Kolos Kórháza
City
Esztergom
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Győr
Country
Hungary
Facility Name
Bács-Kiskun Megyei Önkormányzat Kórháza
City
Kecskemet
Country
Hungary
Facility Name
SZTE ÁOK Ortopédiai Klinika
City
Szeged
Country
Hungary
Facility Name
Fejér Megyei Szent György Kórház
City
Szekesfehervar
Country
Hungary
Facility Name
Tolna Megyei Önkormányzat Balassa János Kórháza
City
Szekszárd
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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