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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02078336
First received: February 24, 2014
Last updated: February 28, 2014
Last verified: November 2013
  Purpose

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

Condition Intervention Phase
Dental Care for Disabled
Drug: Midazolam Mylan
Drug: Lorazepam Mylan
Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Level of cooperation of patient when receiving regular dental care [ Time Frame: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of vital parameters during regular dental care delivery [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078336

Contacts
Contact: Dominique Declerck dominique.declerck@med.kuleuven.be
Contact: Ine Opsomer ine.opsomer@uzleuven.be

Locations
Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Dominique Declerck       dominique.declerck@med.kuleuven.be   
Contact: Ine Opsomer       ine.opsomer@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Dominique Declerck Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02078336     History of Changes
Other Study ID Numbers: S55859, 2013-003991-11
Study First Received: February 24, 2014
Last Updated: February 28, 2014
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Atropine
Diazepam
Midazolam
Droperidol
Biperiden
Biperiden lactate
Lorazepam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014