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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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.

Detailed Description

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The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia.

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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Postoperative Pain Wisdom Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Conventional ibuprofen

Group Type ACTIVE_COMPARATOR

ibuprofen

Intervention Type DRUG

Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery

Bupivacaine

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Brufen retard

Intervention Type DRUG

Single dose 2 x 800mg tablets 2 hours prior to surgery

Bupivacaine

Intervention Type DRUG

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

Intervention Type DRUG

ibuprofen

Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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sustained release ibuprofen modified release ibuprofen Brufen neurofen conventional release ibuprofen Marcain 0.5% with 1 in 200,000 epinephrine

Eligibility Criteria

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Inclusion Criteria

* healthy male and female patients aged 18 years and over
* 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

* history of allergy to NSAIDs
* pregnant
* history of GI disease
* history of bleeding disorders
* alcohol dependancy
* drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

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

Site Status

Central Manchester NHS Foundation Trust

Manchester, Lancashire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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9938

Identifier Type: -

Identifier Source: org_study_id

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