Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

Study Overview
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Brief Summary
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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: To assess the level of cooperation during regular dental care using different procedural sedation protocols To assess patient safety during regular dental care using different sedation protocols To assess patient comfort and possible side-effects after regular dental care using different sedation protocols

Official Title
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Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

Conditions
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Dental Care for Disabled

Intervention / Treatment
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* Drug: Midazolam Mylan
* Drug: Lorazepam Mylan
* Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age 18yrs Patient resides at least 6 months in nursing home het Gielsbos. Patient always gets a sedative protocol to make dental care delivery possible. Informed consent was obtained from parent/guardian No medical contra-indication for any of tested sedative protocols Exclusion Criteria: Age under 18yrs The patient is no resident of the nursing home het Gielsbos or lives there for less than 6 months. No need for medicinal support during dental treatment No informed consent was obtained by parents or the guardian of the patient. Medical contra-indication for 1 of the sedative protocols

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam<br>Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment | Drug: Midazolam Mylan<br> <br> |
| Active Comparator: Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat<br>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 | Drug: Lorazepam Mylan<br> <br> Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of vital parameters during regular dental care delivery | The measure is a composite of recording of blood pressure recording of pulse recording of oxygen saturation | 24 hrs | 
| Level of patient comfort and possible side-effects after dental treatment session | The measure of patient comfort and possible side-effects after dental treatment session is a composite of changes in appetite changes in toilet behavior changes in level of consciousness changes in level of concentration changes in pattern of epileptic insults changes in mood changes in sleeping pattern changes in level of motor skills | 24 hrs |