Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country159 target enrollmentNovember 24, 2021

Overview

Phase: Phase 3
Intervention: Dexmedetomidine Hydrochloride Nasal Spray
Conditions: Preoperative Sedation of Children
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 159
Locations: 1
Primary Endpoint: Proportion of subjects who meet parent-child separation successful
Status: Completed
Last Updated: 3 years ago

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.

Registry

clinicaltrials.gov

Start Date

November 24, 2021

End Date

May 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Not suitable for nasal spray
•Pediatric populations requiring special care or court/social welfare supervision
•Subjects who had been under general anesthesia when they were randomized
•Subjects with a history of mental illness and a history of cognitive impairment epilepsy
•Subjects with cardiovascular disease
•Subjects whose hemoglobin is below the lower limit of normal
•Subjects with a history or possibility of a difficult airway
•Abnormal liver function and/or abnormal renal function
•Adrenoceptor agonists or antagonists or analgesics were used before randomization
•Participated in clinical trials (received experimental drugs)

Intervention: Dexmedetomidine Hydrochloride Nasal Spray

Intervention: Dexmedetomidine hydrochloride nasal spray blank preparation

Proportion of subjects who meet parent-child separation successful

Time Frame: within 45 minutes after the beginning of administration

Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration

Time Frame: within 45 minutes after the beginning of administration

Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration(Within 45 minutes after the beginning of administration)
Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days(an average of 3 days)
Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration(Within 45 minutes after the beginning of administration)
Time from the beginning of administration to the satisfactory Ramsay score for the first time(from the beginning of administration to the first successful Ramsay score)
Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration(within 45 minutes after the beginning of administration)
Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days(an average of 3 days)
Time of anesthesia awakening through study completion，an average of 3 days(an average of 3 days)