Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
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ClinicalTrials.gov Identifier: NCT00344045 |
Recruitment Status
:
Completed
First Posted
: June 26, 2006
Last Update Posted
: November 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Paracetamol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |
Arm | Intervention/treatment |
---|---|
Active Comparator: A |
Drug: Paracetamol
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
Other Name: Perfalgan
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Placebo Comparator: B |
Drug: Placebo
IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
|
- 24-hour cumulative dose of tramadol [ Time Frame: 24 hours, defining TO as the start time of the first dose of study drug ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344045
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00344045 History of Changes |
Other Study ID Numbers: |
CN145-010 |
First Posted: | June 26, 2006 Key Record Dates |
Last Update Posted: | November 4, 2015 |
Last Verified: | October 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 |