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

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

Study Overview

• Status: Unknown
• Conditions: Dental Care for Disabled
• Intervention / Treatment: Drug: Midazolam Mylan; Drug: Lorazepam Mylan; Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dominique Declerck; Email: dominique.declerck@med.kuleuven.be
• Study Contact Backup: Name: Ine Opsomer; Email: ine.opsomer@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Katholieke Universiteit Leuven
    • Contact: Dominique Declerck; Email: dominique.declerck@med.kuleuven.be
    • Contact: Ine Opsomer; Email: ine.opsomer@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Midazolam; Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment	Drug: Midazolam Mylan
ACTIVE_COMPARATOR: Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat; 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; Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dominique Declerck, KU Leuven

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): August 1, 2014
• Study Completion (ANTICIPATED): August 1, 2014

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Mydriatics; Midazolam; Atropine; Lorazepam; Droperidol; Biperiden
• Other Study ID Numbers: S55859; 2013-003991-11 (EUDRACT_NUMBER)