Midazolam Sedation in Dentally Anxious Patients

Study Overview
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Brief Summary
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Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route

Detailed Description
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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.

Official Title
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Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)

Conditions
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Dental Anxiety

Intervention / Treatment
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* Other: Conscious sedation for dental care
* Drug: midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral midazolam<br>oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. | Other: Conscious sedation for dental care<br> <br> Drug: midazolam<br> <br> |
| Other: intravenous midazolam<br>intravenous administration of midazolam at the individual dose determined in session 1 | Other: Conscious sedation for dental care<br> <br> Drug: midazolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | During the first dental care procedure (at day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | at T8 (end of dental treatment) | 
| 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) | 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) | 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) | 48 hours after dental care (T14). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conscious sedation, Dental anxiety, Oral midazolam, Intravenous midazolam, Behaviour