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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003991-11 | EudraCT Number |
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The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability.
The primary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Experimental | Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment |
|
| Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat | Active Comparator | Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment OR Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment + Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment + Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment + Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam Mylan | Drug |
| ||
| Lorazepam Mylan |
| Measure | Description | Time Frame |
|---|---|---|
| Level of cooperation of patient when receiving regular dental care | Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of vital parameters during regular dental care delivery | The measure is a composite of
| 24 hrs |
| Level of patient comfort and possible side-effects after dental treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Declerck | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholieke Universiteit Leuven | Leuven | 3000 | Belgium |
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|
| Valium + Akineton + Dehydrobenzperidol + Atropine sulfate | Drug |
|
The measure of patient comfort and possible side-effects after dental treatment session is a composite of
|
| 24 hrs |
| ID | Term |
|---|---|
| D003975 | Diazepam |
| D001712 | Biperiden |
| D004329 | Droperidol |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053961 | Azabicyclo Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D001562 | Benzimidazoles |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
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