Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
The progress of the study is described below: Session 1: intravenous administration of midazolam. Establishment of the individual dose. Randomisation. Session 2 : Group A : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. Group B : intravenous administration of midazolam at the individual dose determined in session 1. Session 3 : reversal of the procedures : Group A : intravenous administration of midazolam at the individual dose determined in session 1. Group B : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
CHU Clermont-Ferrand
Clermont-Ferrand, France
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Time frame: At the first contact with the dentist (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Time frame: During venous cannulation (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Time frame: During the first injection of local anaesthesia (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Time frame: During the first dental care procedure (at day 1)
The level of patient stress which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Time frame: at T1 (first contact)
The level of patient stress which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
Time frame: at T8 (end of dental treatment)
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Satisfaction level of the patient which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Time frame: 48 hours after dental care (T14).
Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Time frame: 48 hours after dental care (T14).
Satisfaction level of the operator which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
Time frame: 48 hours after dental care (T14).