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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
intranasal administration of dexmedetomidine
Change of MDAS score
Dental anxious score will be accessed by modified dental anxiety scale (MDAS), and the change of MDAS score will be calculated as the scores right after dental treatments minus the initial score before intervention.
Time frame: Change from baseline MDAS score right after finishing dental treatments, an average of 30 minutes
Change of plasma cortisol concentration
The change of plasma cortisol concentration will be calculated as the values right after dental treatments minus the initial values before intervention.
Time frame: Change from baseline plasma cortisol concentration right after finishing dental treatments, an average of 30 minutes
Change of NTI score
The depth of sedation will be accessed by NTI score using Narcotrend, and the change of NTI score will be calculated as the score right after dental treatments minus the initial score before intervention.
Time frame: Change from baseline NTI score right after finishing dental treatments, an average of 30 minutes
Change of OAA/S score
OAA/S score will be accessed by observer's assessment of alertness/sedation scale (OAA/S), which also represent the depth of sedation, and the change of OAA/S score will be calculated as the score right after dental treatments minus the initial score before intervention.
Time frame: Change from baseline OAA/S score right after finishing dental treatments, an average of 30 minutes
Change of blood pressure (BP)
BP will be continuously accessed using an electrocardiogram monitor throughout the whole clinical process. BP value will be converted into mean arterial pressure (MAP) for comparison using the formula: MAP = (SBP + 2 × DBP)/3. Then the change of BP was presented as ΔMAP, which was calculated as the MAP at the point with the highest SBP minus the initial MAP right before the procedure.
Time frame: Change from baseline BP right after finishing dental treatments, an average of 30 minutes.
Change of heart rate (HR)
HR will be continuously accessed using an electrocardiogram monitor throughout the whole clinical process. Change of HR equaled the corresponding HR of the highest SBP subtracted by the initial HR.
Time frame: Change from baseline HR right after finishing dental treatments, an average of 30 minutes.
Pain score
Pain score will be obtained via visual analogue scale (MDAS) for the subject to fill.
Time frame: Through the completion of dental treatments, an average of 30 minutes.
Percentage of thinking feasible of intranasal dexmedetomidine by participants
The feasibility of intranasal dexmedetomidine will be assessed through semistructured questionnaires. Items includes the reasons for nonparticipation; the acceptability of the trial and intranasal dexmedetomidine to participants; and the experience of the patients, the clinician performing the procedure, and the nursing staff taking care for patients during the study. The patients and clinic staffs filled the questionnaires right after the extraction process under our instruction. The outcome of the questionnaires was analyzed through counting and reported as a percentage (%).
Time frame: Through the completion of dental treatments, an average of 30 minutes.
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