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:
Bristol-Myers Squibb
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
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
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 |
|---|---|
| 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) |
| 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
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
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:
| 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 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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 September 27, 2016