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

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: NCT00344045
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Paracetamol Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty
Study Start Date : April 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Paracetamol
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
Other Name: Perfalgan
Placebo Comparator: B Drug: Placebo
IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours


Outcome Measures
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Primary Outcome Measures :
  1. 24-hour cumulative dose of tramadol [ Time Frame: 24 hours, defining TO as the start time of the first dose of study drug ]

Secondary Outcome Measures :
  1. Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs. [ Time Frame: 24 hours, defining TO as the start time of the first dose of study drug ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT00344045


Locations
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Spain
Local Institution
Alcorcon, Spain, 28922
Local Institution
Barcelona, Spain, 08024
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28041
Local Institution
Vizcaya, Spain, 48903
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00344045    
Other Study ID Numbers: CN145-010
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: October 2015
Keywords provided by Bristol-Myers Squibb:
Subjects with postoperative pain after Total Hip Arthroplasty
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Antipyretics