The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group.
In the high weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles. In the high weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles.
In the high weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, China
RECRUITINGAdverse Event and Serious Adverse Event
Incidence rate of Adverse Event and Serious Adverse Event
Time frame: Day2
Maximum blood concentration
Maximum blood concentration
Time frame: 0 to 4 hour after administration
Ramsay scale
Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 1,2, 3, 4,5,6; the minimum value is 1 , the maximum value is 6, higher scores mean a better outcome.
Time frame: 0 minute to 45 minutes after administration
Sedation Success Rate
Proportion of subjects who will accomplish to start the anesthetic indcution or medical procedure
Time frame: 0 minute to 45 minutes after administration
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In the low weight group, 8 subjects will receive a low dose of Dexmedetomidine hydrochloride Microneedles. In the low weight group, 8 subjects will receive a high dose of Dexmedetomidine hydrochloride Microneedles.
In the low weight group, 8 subjects will receive Dexmedetomidine hydrochloride Microneedles blank preparation.