Midazolam Sedation in Dentally Anxious Patients

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.

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