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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00344045

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
A: Active Comparator	Drug: Paracetamol IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
B: Placebo Comparator	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
Genders Eligible for Study:	Both
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

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

Locations

Spain
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28007
Local Institution
Vizcaya, Spain, 48903
Local Institution
Barcelona, Spain, 08024
Local Institution
Alcorcon, Spain, 28922

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN145-010
Study First Received:	June 23, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00344045 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:

Subjects with postoperative pain after Total Hip Arthroplasty

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Analgesics, Non-Narcotic
Pain

Peripheral Nervous System Agents
Analgesics
Acetaminophen
Pain, Postoperative

Additional relevant MeSH terms:

Physiological Effects of Drugs
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Acetaminophen

ClinicalTrials.gov processed this record on September 11, 2009