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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00344045

First received: June 23, 2006

Last updated: October 12, 2015

Last verified: October 2015

History of Changes

Purpose

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	Intervention	Phase
Pain	Drug: Paracetamol Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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:

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 ]


Enrollment:	86
Study Start Date:	April 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344045

Locations


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


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00344045 History of Changes
Other Study ID Numbers:	CN145-010
Study First Received:	June 23, 2006
Last Updated:	October 12, 2015

Keywords provided by Bristol-Myers Squibb:


Subjects with postoperative pain after Total Hip Arthroplasty

Additional relevant MeSH terms:


Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms	Analgesics Acetaminophen Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Antipyretics

ClinicalTrials.gov processed this record on July 24, 2017

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