Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
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| ClinicalTrials.gov Identifier: NCT00508495 |
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Recruitment Status
:
Completed
First Posted
: July 30, 2007
Last Update Posted
: August 11, 2011
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Sponsor:
Baxter Healthcare Corporation
Collaborator:
MDS Pharma Services
Information provided by:
Baxter Healthcare Corporation
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Brief Summary:
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative | Drug: Paracetamol (acetaminophen) Drug: Paracetamol 1% solution Drug: 0.9% sodium chloride solution | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 148 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | March 2008 |
| Actual Study Completion Date : | March 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hip Replacement
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Experimental: Test drug |
Drug: Paracetamol 1% solution
Four 100 mL, 15 min IV infusions at six hour intervals
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| Active Comparator: Reference drug |
Drug: Paracetamol (acetaminophen)
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Perfalgan
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| Placebo Comparator: Placebo |
Drug: 0.9% sodium chloride solution
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Normal saline solution
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Primary Outcome Measures
:
- Amount of PCA-administered morphine consumed during first six hours of study drug treatment [ Time Frame: 6 hours from first (of four) study drug doses ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
- Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.
Exclusion Criteria:
- Another acute or chronic painful physical condition
- Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
- Inability to use and understand Visual Analog Scale and Verbal Rating Score
Information from the National Library of Medicine
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): NCT00508495
Locations
| Hungary | |
| Semmelweis Egyetem Ortopédiai Klinika | |
| Budapest, Hungary | |
| Réthy Pál Kórház-Rendelőintézet | |
| Békéscsaba, Hungary | |
| Esztergom Város Önkormányzat Vaszary Kolos Kórháza | |
| Esztergom, Hungary | |
| Petz Aladár Megyei Oktató Kórház | |
| Győr, Hungary | |
| Bács-Kiskun Megyei Önkormányzat Kórháza | |
| Kecskemet, Hungary | |
| SZTE ÁOK Ortopédiai Klinika | |
| Szeged, Hungary | |
| Fejér Megyei Szent György Kórház | |
| Szekesfehervar, Hungary | |
| Tolna Megyei Önkormányzat Balassa János Kórháza | |
| Szekszárd, Hungary | |
Sponsors and Collaborators
Baxter Healthcare Corporation
MDS Pharma Services
Investigators
| Study Director: | Keyvan Tadjalli Mehr, MD, MSc | Baxter Deutschland GmbH |
| Responsible Party: | Keyvan Tadjalli Mehr, MD, MSc/Medical Director, Baxter Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00508495 History of Changes |
| Other Study ID Numbers: |
R-01270-A016 EudraCT 2006-004075-36 |
| First Posted: | July 30, 2007 Key Record Dates |
| Last Update Posted: | August 11, 2011 |
| Last Verified: | August 2011 |
Keywords provided by Baxter Healthcare Corporation:
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pain, postoperative replacement, total hip total hip replacement arthroplasty, replacement, hip |
Additional relevant MeSH terms:
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Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Pharmaceutical Solutions |
Acetaminophen Analgesics Analgesics, Non-Narcotic Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |