Back to resultsStudy to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
Primary Purpose
Pain
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Subjects with postoperative pain after Total Hip Arthroplasty
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
24-hour cumulative dose of tramadol
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344045
Brief Title
Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Subjects with postoperative pain after Total Hip Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Vizcaya
ZIP/Postal Code
48903
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
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