A comparison of patient-controlled sedation and operator-controlled intravenous sedation with midazolam in patients undergoing surgical removal of impacted third molars
ISRCTN | ISRCTN43878832 |
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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
Scientific
Holtye Road
West Sussex
East Grinstead
RH19 3DZ
United Kingdom
Phone | +44 (0)1342 414000 |
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hf@cct.com |
Study information
Study design | A randomised cross-over prospective trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Midazolam |
Primary outcome measure | 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 study start date | 01/04/2004 |
Completion date | 30/10/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | N = 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
- England
- United Kingdom
Study participating centre
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
RH19 3DZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
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Funders
Funder type
Government
Queen Victoria Hospital NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
03/01/2020: No publications found, all search options exhausted, study status unverified.