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

Phase 4

Active, not recruiting

• Conditions: Dental Care for Disabled
• Interventions: Drug: Lorazepam Mylan; Drug: Midazolam Mylan; Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

• Registration Number: NCT02078336
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat	Lorazepam Mylan	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
Midazolam	Midazolam Mylan	Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat	Valium + Akineton + Dehydrobenzperidol + Atropine sulfate	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Recording of vital parameters during regular dental care delivery	24 hrs	The measure is a composite of; * recording of blood pressure; * recording of pulse; * recording of oxygen saturation
Level of patient comfort and possible side-effects after dental treatment session	24 hrs	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

Trial Locations

Locations (1)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium