Protective analgesia using bupivacaine and conventional release ibuprofen versus bupivacaine and sustained release ibuprofen for postoperative pain relief in patients undergoing third molar surgery: a randomised controlled trial. - Protective analgesia for postoperative pain relief

Phase 1

• Conditions: Pain following surgical removal of impacted lower wisdom tooth/ teeth.

• Registration Number: EUCTR2006-000193-77-GB
• Lead Sponsor: The University of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 125

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified