Pain following surgical removal of impacted lower wisdom tooth/ teeth.
Conditions
Interventions
Trade Name: Brufen Retard
Pharmaceutical Form: Tablet
Trade Name: Ibuprofen
Pharmaceutical Form: Tablet
Trade Name: Marcain 0.5%
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent. 2.Male or female outpatients scheduled for surgical removal of one or more impacted mandibular third molar, where bone removal is judged to be needed and, if medically indicated, removal of the ipsilateral third molar in the upper jaw (indication for removal according to recently published NICE guideline). 3.Age 18 years and over. 4.BMI no more than 35 (kgm-2). 5.Be able and to understand and comply with all study requirements. 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.History of significant psychiatric or somatic disease or other previous disease/condition or surgery which may interfere with the study objectives, as judged by the investigator. 2.History of gastro-intestinal ulceration or significant dyspepsia, as judged by the investigator. 3.History of easy bruising,bleeding, as judged by the investigator or known bleeding disorder eg haemophilia or Von Willebrands syndrome. 4.Oral surgical intervention in the 30 days prior to the pre-study visit. 5.Known hypersensitivity (ie, asthma, rhinitis, urticaria) or any form of allergic reaction to Brufen Retard(sustained release ibuprofen 800mg), local anaesthetic of the amide type Marcain(bupivacaine), paracetamol or any other condition where these drugs are contra-indicated, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Number of patients needing rescue medication within 6 hours following surgery.;Main Objective: Improve postoperative pain experience for patients undergoing third molar surgery.;Secondary Objective: To test the concept of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following third molar surgery. | — |
Countries
United Kingdom
Outcome results
None listed