Status:
COMPLETED
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatm...
Eligibility Criteria
Inclusion
- ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
- Moderate or severe pain within 4 hours after the completion of surgery.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00406679
Start Date
November 1 2006
End Date
October 1 2007
Last Update
August 11 2011
Active Locations (2)
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1
University Dental Hospital of Manchester
Manchester, England, United Kingdom
2
University Dental Hospital NHS Trust Cardiff
Cardiff, Wales, United Kingdom