Condition category
Oral Health
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ana-Maria Roman

ORCID ID

Contact details

Holtye Road
West Sussex
East Grinstead
RH19 3DZ
United Kingdom
+44 (0)1342 414000

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0190137104

Study information

Scientific title

Acronym

Study hypothesis

To assess the safety and effectiveness of patient-controlled sedation with midazolam compared with the currently used technique of operator-controlled sedation with midazolam in healthy patients undergoing surgical removal of lower third molars.

Ethics approval

Not provided at time of registration

Study design

A randomised cross-over prospective trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgical removal of impacted third molars

Intervention

N = 64 (+ 20% to allow for drop-outs) p = 0.05; power 0.8; effect size 0.3; tests: repeated measures t-test (normal distribution) or Wilcoxon signed ranks test (non-parametric).

Patients are randomised to:
1. Patient-controlled sedation with midazolam
2. Operator-controlled sedation with midazolam

Intervention type

Drug

Phase

Not Specified

Drug names

Midazolam

Primary outcome measures

1. Demographic, medical and dental status
2. Duration of sedation induction and operation
3. Level of sedation (score at 10, 20, 30 minutes following the end of the procedure)
4. Operating conditions
5. Vital signs
6. Anxiety assessment (by asking the patients to indicate their level of anxiety on a visual analogue scale [VAS] - 100 mm)
7. Memory and acceptability - once recovered, patients are asked whether they can remember specific events during the appointment. Following the second appointment, patients are asked to specify which session provided the most acceptable level of sedation and anxiolysis.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2004

Overall trial end date

30/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. American Society of Anaesthesiologists (ASA) grade I - II
2. Require surgical removal of bilateral similarly impacted lower third molars (equal surgical difficulty) at two visits
3. Can bring a responsible person to accompany them home

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

N = 64

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2004

Recruitment end date

30/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Holtye Road
East Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen Victoria Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes