Midazolam Sedation in Dentally Anxious Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-08-31

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

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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.

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral midazolam

oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.

Group Type EXPERIMENTAL

Conscious sedation for dental care

Intervention Type OTHER

midazolam

Intervention Type DRUG

intravenous midazolam

intravenous administration of midazolam at the individual dose determined in session 1

Group Type OTHER

Conscious sedation for dental care

Intervention Type OTHER

midazolam

Intervention Type DRUG

Interventions

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Conscious sedation for dental care

Intervention Type OTHER

midazolam

Intervention Type DRUG

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No