dentophobia intellectual disability
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexmedetomidine
CAS Number: 145108-58-3
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Concentration unit: µg
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Intellectual Disability of DSM-V classes Mild to Profound 2. Documented failure to tolerate the indicated dental treatment with non-pharmacological support. 3. Indication for dental treatment under general anesthesia because of 1 and 2. 4. Completed and cleared through the pre-anesthetic screening as per the standard protocol of the UMCGs department of anesthesiology 5. Adult, men and women, 18-55 years of age, inclusive. 6. Body Mass Index (BMI) = 17.5 and = 35 kg/m2, inclusive, and a total body weight >50 kg, at screening and check-in. 7. American Society of Anesthesiologists (ASA) Physical Status 1-3 8. Able to understand the study procedures as described in the patient information sheet, willing and able to comply with the protocol, and to provide written informed consent OR in the case of legal incapability: a guardian understanding the study procedures as described in the patient information sheet, provides written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindications for the use of dexmedetomidine 2. Known intolerance to dexmedetomidine 3. History or presence of significant cardiovascular disease (ASA >3), or significant cardiovascular disease risk factors, significant coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.) 4. History or presence of significant (ASA >3) pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, disease. 5. History of any illness or medication use that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the subject by their participation in the study. 6. Difficulty in airway management anticipated by the attending anesthesiologist . 7. Surgery within the past 90 days prior to dosing judged by the PI to be clinically relevant. 8. History of febrile illness within 5 days prior to dosing. 9. History or presence of alcoholism or drug abuse within the past 2 years. 10. Hypersensitivity or idiosyncratic reaction to components of dexmedetomidine, , or to compounds related to the study medications. 11. Patients refusal or, in case of legal incapability: 12. Guardians refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of a single dose of intranasal dexmedetomidine for conscious sedation of patients with intellectual disability with dentophobia to treatment under general anesthesia;Secondary Objective: To assess the ease of induction of general anesthesia in patients with intellectual disabilities and dentophobia after a single dose of intranasal dexmedetomidine.;Primary end point(s): • Proportion of patients in whom dental treatment under procedural sedation with intranasal dexmedetomidine can be finished and is not terminated because of inadequate sedation. • Proportion of patients in whom dental treatment under general anesthesia can be finished and is not terminated because of inadequate sedation. • mRASS-score at specified dental treatment events after dexmedetomidine treatment compared to agitation score descriptor from the non-pharmacological Trial-of-Treatment • mRASS-score at specified events during induction for general anesthesia compared to agitation score descriptor from the non-pharmacological Trial-of-Treatment ;Timepoint(s) of evaluation of this end point: From start of dental treatment until comlpetion of dental treatment or until induction of general anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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”. • Progress made in dental treatment as compared to earlier Trial-of-Treatment without pharmacological support ;Timepoint(s) of evaluation of this end point: From start of dental treatment until comlpetion of dental treatment or until induction of general anesthesia | — |
Countries
Netherlands
Contacts
Public ContactTrialcoordinator
University Medical Center Groningen
Outcome results
None listed