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

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00508495
First received: July 26, 2007
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Pain, Postoperative
 Drug: Paracetamol (acetaminophen)
Drug: Paracetamol 1% solution
Drug: 0.9% sodium chloride solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 26, 2007
Last Updated: August 10, 2011
Health Authority: Hungary: National Institute of Pharmacy

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Analgesics
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013