A comparison of patient-controlled sedation and operator-controlled intravenous sedation with midazolam in patients undergoing surgical removal of impacted third molars

ISRCTN	ISRCTN43878832
DOI	https://doi.org/10.1186/ISRCTN43878832
Protocol serial number	N0190137104
Sponsor	Department of Health
Funder	Queen Victoria Hospital NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 03/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ana-Maria Roman
Scientific

Holtye Road
West Sussex
East Grinstead
RH19 3DZ
United Kingdom

Phone	+44 (0)1342 414000
Email	hf@cct.com

Study information

Primary study design	Interventional
Study design	A randomised cross-over prospective trial.
Secondary study design	Randomised controlled trial
Scientific title	-
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Midazolam
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/10/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	64
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2004
Date of final enrolment	30/10/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Holtye Road

East Grinstead
RH19 3DZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

03/01/2020: No publications found, all search options exhausted, study status unverified.