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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000200-14-GB

Enrollment

Registered

2005-04-21

Start date

2005-07-08

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain experienced after the surgical removal of impacted third molars.

Interventions

Trade Name: "Toradol" (Ketoralac Trometamol) Product Name: "Toradol" (Ketoralac Trometamol) Product Code: PL 0031/0481 Pharmaceutical Form: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026