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Randomized Controlled Trial
. 2024 Sep 6;24(1):315.
doi: 10.1186/s12871-024-02708-1.

Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

Jia Gao  1 , Fang Wang  1 , Xiaoling Wang  2 , Xiaohua Zou  3 , Hua-Cheng Liu  4 , Xingrong Song  5 , Xiaoqing Chai  6 , Rong Jiang  7 , Ping Zhao  8 , Jiaqiang Zhang  9 , Sai-Ying Wang  10 , Haichun Ma  11 , Zhibin Zhao  12 , Quanren Wang  13 , Na Zhou  13 , Jianling Bai  14 , Jianmin Zhang  15
Affiliations
Randomized Controlled Trial

Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

Jia Gao et al. BMC Anesthesiol. .

Abstract

Background: Off-label intranasal administration of injectable dexmedetomidine has been widely applied in the pediatric sedation setting. However, the development of an improved drug delivery system that is easy to use is needed. We developed a novel dexmedetomidine nasal spray that can be administered directly without dilution or configuration for pediatric pre-anesthetic sedation. This nasal spray has a fixed dose and is stable during storage. To the best of our knowledge, this is the first licensed nasal spray preparation of dexmedetomidine worldwide.

Objective: To evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children.

Methods: The study was conducted at 11 sites in China between 24 November 2021 and 20 May 2022 and was registered in ClinicalTrials.gov (NCT05111431, first registration date: 20/10/2021). Subjects (n = 159) between 2 and 6 years old who were to undergo elective surgery were randomized to the dexmedetomidine group (n = 107) or the placebo group (n = 52) in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the stratified body weight. The primary outcome measure was the proportion of subjects who achieved the desired child-parent separation and Ramsay scale ≥ 3 within 45 min of administration. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation.

Results: The proportion of subjects achieving desired parental separation and Ramsay scale ≥ 3 within 45 min was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) (P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach desired parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity.

Conclusions: This novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.

Keywords: Dexmedetomidine; Intranasal; Pediatric; Pre-anesthetic; Sedation.

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Conflict of interest statement

This study was sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Quanren Wang and Na Zhou are employees of Jiangsu Hengrui Pharmaceuticals Co., Ltd. No other authors declared potential competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Heart rate (A), respiratory rate (B), systolic blood pressure (C), diastolic blood pressure (D), and SpO2 (E) at baseline and at each pre-determined time point post treatment. Values are mean ± standard deviation. Abbreviation: SpO2, blood oxygen saturation
See this image and copyright information in PMC

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