Post-surgical dental pain after removal of one or more impacted 3rd mandibular molar(s), associated with moderate to severe pain.
Conditions
Interventions
Product Name: Paracetamol 1% Bioren
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
Concentration unit: % (W/V) percent weig
Sponsors
Baxter R&D Europe S.C.R.L
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male / female patients, 18-65 years of age inclusive. 2. Body mass index (BMI) 18-35 3. Patient is in good health as determined by the Principal Investigator on the basis of medical history and physical examination. 4. American Society of Anesthesia (ASA) Grade I or Grade II 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. 5. Patient has provided written informed consent prior to performing any study related procedures. 6. A negative urine pregnancy test for all female patients of childbearing potential (a female is considered to be of childbearing potential if they have not been postmenopausal for at least 24 consecutive months or if they have a uterus and at least one ovary) immediately before surgery. 7. Patients will be randomized and assigned medication if they rate their pain as moderate or severe assessed on a four-point verbal rating scale (VRS) within 4 hours after the completion of surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Another acute or chronic painful physical condition. 2. The use of nonsteroidal antiinflammatory drugs (NSAIDs), including aspirin, or other analgesic drugs within the 24 hours preceding administration of study medication. Specifically excluded are tricyclic antidepressants (TCAs), narcotic analgesics, antihistamines, tranquilizers, hypnotics, sedatives, Cyclooxegenase-2 (COX-2) specific inhibitors and corticosteroids. 3. The use of any anticoagulant including heparin, warfarin and low-molecular weight heparins at screening and throughout the study. 4. The patient has a history of uncontrolled chronic disease, which in the opinion of the Principal Investigator would contraindicate study participation. 5. Inability to use or understand the visual analog scale (VAS) pain score and/or the Verbal Rating Score (VRS). 6. Liver dysfunction defined as an elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamyl transpeptidase (GGT) 3 times above the upper limit of normal (ULN). 7. Advanced renal dysfunction defined as an elevation of serum creatinine 3 times the ULN. 8. Psychiatric or medical conditions which would preclude safe surgery. 9. Concomitant use of sedatives or microsomal enzyme inducers. 10. Pregnant or lactating women. 11. Women of childbearing potential not using adequate contraception. 12. Acute, local infection involving the oral cavity. 13. Known sensitivity to the NSAID class of drugs, paracetamol or other analgesics. 14. A contraindication to paracetamol. 15. History of non-response to paracetamol. 16. A bleeding disorder. 17. Any history of gastrointestinal bleeding. 18. Any laboratory abnormality, which in the opinion of the Principal Investigator would preclude study participation. 19. Risk of infectious endocarditis. 20. History of analgesic, narcotic or alcohol dependance (substance abuse). 21. Cardiac valvular disease. 22. History of participating in another clinical investigation, or taking another investigational drug within the month prior to surgery. 23. Dehydration or chronic malnutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of paracetamol (Paracetamol 1% solution Bioren, test) compared to placebo in patients with moderate or severe pain following oral surgery.; Secondary Objective: - To evaluate the analgesic efficacy of paracetamol (Paracetamol 1% solution Bioren, test) compared to Perfalgan® (reference). - To evaluate the analgesic efficacy of Perfalgan® (reference) compared to placebo. - To compare tolerability at the infusion site between paracetamol (Paracetamol 1% solution Bioren, test) and Perfalgan® (reference). - To assess the safety profile between paracetamol (Paracetamol 1% solution Bioren, test) and Perfalgan® (reference). ;Primary end point(s): The primary outcome measurement (primary efficacy variable) will be Total Pain Relief (TOTPAR-6), defined as the sum of scores weighted for time elapsing between observations from T15 min to T6 h, and is an estimate of the area under the curve of PR over time. | — |
Countries
United Kingdom
Outcome results
None listed