Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery
NCT ID: NCT00895843
Last Updated: 2009-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2006-11-30
2008-01-31
Brief Summary
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Detailed Description
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The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia.
The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Conventional ibuprofen
ibuprofen
Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
Bupivacaine
Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
Brufen retard
Brufen retard
Single dose 2 x 800mg tablets 2 hours prior to surgery
Bupivacaine
Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
Interventions
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Brufen retard
Single dose 2 x 800mg tablets 2 hours prior to surgery
ibuprofen
Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
Bupivacaine
Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal
Exclusion Criteria
* pregnant
* history of GI disease
* history of bleeding disorders
* alcohol dependancy
* drug abuse
18 Years
65 Years
ALL
Yes
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
University of Manchester
OTHER
Responsible Party
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University of Manchester
Principal Investigators
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Paul Coulthard, BDS FDS PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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Central Manchester and Manchester Children's NHS University Hospitals
Manchester, Lancashire, United Kingdom
Central Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom
Countries
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Other Identifiers
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9938
Identifier Type: -
Identifier Source: org_study_id
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