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

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 a

SUBMITTER: Gao J 

PROVIDER: S-EPMC11378629 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature