Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability
- Conditions
- DentophobiaIntelelctual disability
- Registration Number
- NL-OMON28972
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Intellectual Disability of DSM-V classes Mild to
Profound
Exclusion Criteria
1. Contraindications for the use of dexmedetomidine
2. Known intolerance to dexmedetomidine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Proportion of patients in whom dental treatment<br><br>under procedural sedation with intranasal dexmedetomidine<br><br>can be finished and is not terminated because of inadequate<br><br>sedation.<br><br /><br>• Proportion of patients in whom dental treatment<br><br>under general anesthesia can be finished and is not<br><br>terminated because of inadequate sedation.<br /><br><br>• mRASS-score at specified dental treatment events<br><br>after dexmedetomidine treatment compared to agitation<br><br>score descriptor from the non-pharmacological Trial-of-<br><br>Treatment<br><br /><br>• mRASS-score at specified events during induction for<br><br>general anesthesia compared to agitation score descriptor<br><br>from the non-pharmacological Trial-of- Treatment
- Secondary Outcome Measures
Name Time Method •Type of dental treatment events tolerated after dexmedetomidine treatment compared to type of dental treatment events tolerated without pharmacological support in the dental policlinic Bijzondere Tandheelkunde”. <br /><br>•Progress made in dental treatment as compared to earlier treatment without pharmacological support<br>