Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Phase 3
Completed
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT00406679
- Lead Sponsor
- Baxter Healthcare Corporation
- 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 treatment which contains no active ingredient).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Paracetamol (acetaminophen) solution experimental - 2 placebo - 3 paracetamol (acetaminophen) solution commercial -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University Dental Hospital of Manchester
🇬🇧Manchester, England, United Kingdom
University Dental Hospital NHS Trust Cardiff
🇬🇧Cardiff, Wales, United Kingdom