Midazolam Sedation in Dentally Anxious Patients

June 10, 2013 updated by: University Hospital, Clermont-Ferrand

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

Use lay language.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
During venous cannulation (at day 1)
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)
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
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)
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
Time Frame: at T1 (first contact)
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
Time Frame: at T8 (end of dental treatment)
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
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)
48 hours after dental care (T14).
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)
48 hours after dental care (T14).
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)
48 hours after dental care (T14).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Valérie Collado, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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