NCT00895843

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

May 8, 2009

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

1.1 years

First QC Date

March 24, 2009

Results QC Date

March 24, 2009

Last Update Submit

May 7, 2009

Conditions

Postoperative PainWisdom Tooth

Keywords

Third molar

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Needing Rescue Medication

    Number of patients who required rescue medication within 6 hours

    At 6 hours

Secondary Outcomes (3)

  • Mean Pain Intensity

    30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery

  • Time to Rescue

    Between 30mins and 48 hours

  • Pain Control/Relief

    48 hours after surgery (end of study)

Study Arms (2)

Conventional ibuprofen

ACTIVE COMPARATOR
Drug: ibuprofenDrug: Bupivacaine

Brufen retard

EXPERIMENTAL
Drug: Brufen retardDrug: Bupivacaine

Interventions

Brufen retardDRUG

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

Also known as: sustained release ibuprofen, modified release ibuprofen
Brufen retard
ibuprofenDRUG

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

Also known as: Brufen, neurofen, conventional release ibuprofen
Conventional ibuprofen
BupivacaineDRUG

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.

Also known as: Marcain 0.5% with 1 in 200,000 epinephrine
Brufen retardConventional ibuprofen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of allergy to NSAIDs
  • pregnant
  • history of GI disease
  • history of bleeding disorders
  • alcohol dependancy
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Manchester and Manchester Children's NHS University Hospitals

Manchester, Lancashire, M13 9PL, United Kingdom

Location

Central Manchester NHS Foundation Trust

Manchester, Lancashire, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

IbuprofenBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAnilidesAmidesAniline CompoundsAmines

Results Point of Contact

Title
Mr Sin L Yong
Organization
University of Manchester
sin.l.yong@manchester.ac.uk
01612756806

Study Officials

  • Paul Coulthard, BDS FDS PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2009

First Posted

May 8, 2009

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

June 1, 2009

Results First Posted

May 8, 2009

Record last verified: 2009-05

Locations

GB(2)