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
Secondary identifying numbers N0190137104
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

Study designA randomised cross-over prospective trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title-
Study objectivesTo 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) studiedSurgical removal of impacted third molars
InterventionN = 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Midazolam
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/04/2004
Completion date30/10/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsN = 64
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/04/2004
Date of final enrolment30/10/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Holtye Road
East Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Queen Victoria Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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