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

Tracking Information

First Received Date ^ICMJE

June 23, 2006

Last Updated Date

September 26, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

24-hour cumulative dose of tramadol

Change History

Complete list of historical versions of study NCT00344045 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Paracetamol
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00344045

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CN145-010

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP