Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial
Status:
Not yet recruiting
Trial end date:
2023-07-23
Target enrollment:
Participant gender:
Summary
Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients
with severe dental anxiety have difficulty cooperating with dental treatments, and can only
complete dental treatments through general anesthesia, or even abandon treatments.
Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good
anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and
intensive care medicine departments, routinely intravenously. In recent years, intranasal
administration of dexmedetomidine has also been reported for pediatric dentistry and adult
alveolar surgery, showing good sedative and analgesic effects. However, these studies have
problems such as single surgical types, small sample size, and few indicators analyzed.
Therefore, the evaluation of intranasal administration of dexmedetomidine is still not
comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety
has not been reported yet. This project plans to carry out a randomized, double-blinded,
placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and
secondly verify it with placebo as the control. We plan to measure the object indicators,
including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and
to assess the subjective indicators using scales and questionnaires, thus comprehensively
evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal
dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism
additionally. We intend to help severe dental anxious patients completing dental treatments.
Phase:
N/A
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University