Clinical trial NCT01874717: Midazolam Sedation in Dentally Anxious Patients
Official title: Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Anxiety
Keywords: Conscious sedation
Dental anxiety
Oral midazolam
Intravenous midazolam
Behaviour
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 131
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Use lay language.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient level of cooperation which is assessed using the French modified version of Venham scale
timeFrame: At the first contact with the dentist (at day 1)
measure: Patient level of cooperation which is assessed using the French modified version of Venham scale
timeFrame: During venous cannulation (at day 1)
measure: Patient level of cooperation which is assessed using the French modified version of Venham scale
timeFrame: During the first injection of local anaesthesia (at day 1)
measure: Patient level of cooperation which is assessed using the French modified version of Venham scale
timeFrame: During the first dental care procedure (at day 1)
Secondary outcomes:
measure: The level of patient stress which is assessed using the French modified version of Venham scale
timeFrame: at T1 (first contact)
measure: The level of patient stress which is assessed using the French modified version of Venham scale
timeFrame: at T8 (end of dental treatment)
measure: Satisfaction level of the patient which is assessed using the French modified version of Venham scale
timeFrame: 48 hours after dental care (T14).
measure: Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale
timeFrame: 48 hours after dental care (T14).
measure: Satisfaction level of the operator which is assessed using the French modified version of Venham scale
timeFrame: 48 hours after dental care (T14).
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Valérie COLLADO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.