Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Paracetamol (acetaminophen) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s):
Jocelyne Flament, MD, Study Director, Affiliation: Baxter Healthcare Corporation
Overall contact:
Sarah Muller, Phone: +44 0 118 933 5381, Email: sarah.muller@mdsinc.com
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).
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Sarah Muller, Phone: +44 0 118 933 5381, Email: sarah.muller@mdsinc.com
SE Orthopedic Clinic, Budapest, Hungary; Not yet recruiting
Réthy Pál Hospital, Békéscsaba, Hungary; Not yet recruiting
Bács-Kiskun County Hospital, Kecskemét, Hungary; Not yet recruiting
Pándy Kálmán Hospital, Gyula, Hungary; Recruiting
Szent György Hospital, Székesféhervár, Hungary; Not yet recruiting
University of Szeged Faculty of Medicine Orthopedic Clinic, Szeged, Hungary; Not yet recruiting
Additional Information
Starting date: August 2007
Ending date: July 2008
Last updated: August 10, 2007
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