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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43878832

Enrollment

Registered

2004-09-30

Start date

2004-04-01

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical removal of impacted third molars Oral Health Impacted third molars

Interventions

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 m

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026