Midazolam Sedation in Dentally Anxious Patients
- Conditions
- Dental Anxiety
- Interventions
- Other: Conscious sedation for dental care
- Registration Number
- NCT01874717
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
-
- 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
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description oral midazolam Conscious sedation for dental care oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. oral midazolam midazolam oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. intravenous midazolam Conscious sedation for dental care intravenous administration of midazolam at the individual dose determined in session 1 intravenous midazolam midazolam intravenous administration of midazolam at the individual dose determined in session 1
- Primary Outcome Measures
Name Time Method Patient level of cooperation which is assessed using the French modified version of Venham scale During the first dental care procedure (at day 1) This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
- Secondary Outcome Measures
Name Time Method The level of patient stress which is assessed using the French modified version of Venham scale at T8 (end of dental treatment) 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)
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France