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
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