Dental Anxiety
Conditions
Keywords
Conscious sedation, Dental anxiety, Oral midazolam, Intravenous midazolam, Behaviour
Brief summary
Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
Detailed description
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.
Interventions
OTHERConscious sedation for dental care
DRUGmidazolam
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* \- Patient between 8 and 60 years, regardless of gender * Patient in the American Society of Anesthesiologists (ASA) category I ou II. * Patient in need of multiple dental care, referred to the Unit of Special Care Dentistry for cooperation difficulties * Patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% N2O/O2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the French modified version of the Venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation. * Written consent signed by the patient or his legal guardian * Patient accompanied by an accountable person
Exclusion criteria
* \- Patient below 8 years or over 60 years-old * Patient in the American Society of Anesthesiologists (ASA) category III or more * Patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment * Patient having received an anxiolytic premedication in the 24 hours preceding the dental care session * Patient already treated under midazolam sedation less than a week ago * Any medical contraindication to the use of midazolam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient level of cooperation which is assessed using the French modified version of Venham scale | At the first contact with the dentist (at day 1) | This scale offers a good description of behaviour and anxiety in one score (from0 to 5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The level of patient stress which is assessed using the French modified version of Venham scale | at T1 (first contact) | This scale offers a good description of behaviour and anxiety in one score (from0 to 5) |
| Satisfaction level of the patient which is assessed using the French modified version of Venham scale | 48 hours after dental care (T14). | This scale offers a good description of behaviour and anxiety in one score (from 0 to 5) |
| Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale | 48 hours after dental care (T14). | This scale offers a good description of behaviour and anxiety in one score (from 0 to 5) |
| Satisfaction level of the operator which is assessed using the French modified version of Venham scale | 48 hours after dental care (T14). | This scale offers a good description of behaviour and anxiety in one score (from 0 to 5) |
Countries
France
Outcome results
None listed