Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Use lay language.
To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral midazolam | Experimental | oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. |
|
| intravenous midazolam | Other | intravenous administration of midazolam at the individual dose determined in session 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conscious sedation for dental care | Other |
| ||
| midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| The level of patient stress which is assessed using the French modified version of Venham scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Valérie COLLADO | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23940729 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016292 | Conscious Sedation |
| D003729 | Dental Care |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D003813 | Dentistry |
| D003752 | Dental Health Services |
| D006296 | Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
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 | 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 | 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 | This scale offers a good description of behaviour and anxiety in one score (from 0 to 5) | 48 hours after dental care (T14). |
| D005159 |
| Health Care Facilities Workforce and Services |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |