Midazolam Sedation in Dentally Anxious Patients

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874717
• Other study ID #: CHU-0155
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2013
• Last updated: June 10, 2013
• Start date: June 2005
• Est. completion date: August 2007

Study information

• Verified date: June 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Use lay language.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Other:
• Conscious sedation for dental care

Drug:
• midazolam

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No