Midazolam Sedation in Dentally Anxious Patients

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2007

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

  • Other: Conscious sedation for dental care
  • Drug: midazolam

Arms, Groups and Cohorts

  • Experimental: oral midazolam
    • oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
  • Other: intravenous midazolam
    • intravenous administration of midazolam at the individual dose determined in session 1

Clinical Trial Outcome Measures

Primary Measures

  • Patient level of cooperation which is assessed using the French modified version of Venham scale
    • Time Frame: 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)
  • Patient level of cooperation which is assessed using the French modified version of Venham scale
    • Time Frame: During venous cannulation (at day 1)
    • This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
  • Patient level of cooperation which is assessed using the French modified version of Venham scale
    • Time Frame: During the first injection of local anaesthesia (at day 1)
    • This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
  • Patient level of cooperation which is assessed using the French modified version of Venham scale
    • Time Frame: 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 Measures

  • The level of patient stress which is assessed using the French modified version of Venham scale
    • Time Frame: at T1 (first contact)
    • This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
  • The level of patient stress which is assessed using the French modified version of Venham scale
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 48 hours after dental care (T14).
    • This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Valérie COLLADO, Principal Investigator, University Hospital, Clermont-Ferrand

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