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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00508495
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : August 11, 2011
Sponsor:
Collaborator:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Paracetamol (acetaminophen) Drug: Paracetamol 1% solution Drug: 0.9% sodium chloride solution Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Test drug Drug: Paracetamol 1% solution
Four 100 mL, 15 min IV infusions at six hour intervals
Active Comparator: Reference drug Drug: Paracetamol (acetaminophen)
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Perfalgan
Placebo Comparator: Placebo Drug: 0.9% sodium chloride solution
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Normal saline solution


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508495


Locations
Hungary
Semmelweis Egyetem Ortopédiai Klinika
Budapest, Hungary
Réthy Pál Kórház-Rendelőintézet
Békéscsaba, Hungary
Esztergom Város Önkormányzat Vaszary Kolos Kórháza
Esztergom, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza
Kecskemet, Hungary
SZTE ÁOK Ortopédiai Klinika
Szeged, Hungary
Fejér Megyei Szent György Kórház
Szekesfehervar, Hungary
Tolna Megyei Önkormányzat Balassa János Kórháza
Szekszárd, Hungary
Sponsors and Collaborators
Baxter Healthcare Corporation
MDS Pharma Services
Investigators
Study Director: Keyvan Tadjalli Mehr, MD, MSc Baxter Deutschland GmbH
More Information

Responsible Party: Keyvan Tadjalli Mehr, MD, MSc/Medical Director, Baxter Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00508495     History of Changes
Other Study ID Numbers: R-01270-A016
EudraCT 2006-004075-36
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by Baxter Healthcare Corporation:
pain, postoperative
replacement, total hip
total hip replacement
arthroplasty, replacement, hip

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pharmaceutical Solutions
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics