A randomised, double-blinded comparison of the effectiveness of intravenously administered Ketoralac versus Dexamethasone in the treatment of pain following surgical removal of third molar teeth under intravenous sedation and local anaesthesia – a pilot study. - North Bristol Oral surgery Intravenous Sedation Study

Phase 1

• Conditions: Pain experienced after the surgical removal of impacted third molars.

• Registration Number: EUCTR2005-000200-14-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients who require the surgical removal of impacted third molars under intravenous sedation and local anaesthesia. These patients will generally be young, fit and healthy.
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

Patients who are known to have an intolerance of non-steroidal anti-inflammatory painkillers, or who have asthma that can be precipitated by the use of non-steroidal anti-inflammatory painkillers.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): Pain experience as recorded on visual analogue scales, up to one week after surgery, (see protocol) when patients will be reviewed on clinic at the department of Oral and Maxillofacial Surgery at Southmead Hospital.;Main Objective: Main objective : The aim of this pilot study is to assess whether there appears to be any benefit (in terms of a reduction of post-operative pain experienced) following the removal of impacted third molars under intravenous sedation and local anaesthesia when additional non-steroidal anti-inflammatory or glucocorticoid are administered prior to commencement of surgery.