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CLINICAL TRIAL article

Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1528612
This article is part of the Research Topic Precision Medicine in Pediatrics - Volume II View all 15 articles

Comparison of a ready-to-use intranasal dexmedetomidine spray with traditional intranasal dexmedetomidine drops for sedation in preschool children: A prospective, randomized, controlled study

Provisionally accepted
Qi-Qi Jin Qi-Qi Jin Wei-Cha Cai Wei-Cha Cai Ying-Feng Zhou Ying-Feng Zhou Yan-Tong Zhang Yan-Tong Zhang Gang Chen Gang Chen Meng-Ting Xu Meng-Ting Xu Jun Li Jun Li *Kai-Ming Yuan Kai-Ming Yuan *
  • Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China

The final, formatted version of the article will be published soon.

    Purpose: This study compared the efficacy and acceptability of a ready-to-use intranasal dexmedetomidine spray (DS) versus traditional drops administered by syringe (DD) in pediatric patients undergoing elective surgery.Patients and Methods: Eighty-six preschool children were enrolled in a prospective, randomized, controlled study. Children were randomly assigned to receive either DS or DD. For children weighing between 10.5 and 18.5 kg, a dexmedetomidine dosage of 30 μg (two sprays) was administered, while those weighing between 18.5 and 25.5 kg received 45 μg (three sprays). In the DD group, dexmedetomidine was administered at a dose of 2 μg/kg based on body weight. The primary outcome was the proportion of children achieving a Ramsay sedation scale (RSS) score of ≥ 3 within 30 minutes. Secondary outcomes included acceptance of intranasal medication, anxiety at parental separation and prior to induction, and compliance with induction.Results: A total of 83 cases were analyzed. The proportion of children achieving an RSS score of ≥ 3 within 30 minutes was similar between the DS and DD groups (90.7% vs. 77.5%, respectively). However, the acceptance score was significantly better in the DS group (mean difference [95%]: -0.9 [-1.267 to -0.5325], P < 0.001). No significant differences were observed between the groups in terms of successful child-parent separation (88.4% vs. 85%) or satisfactory anxiolytic effect prior to induction (95.3% vs. 92.5%). Compliance with induction was comparable, with 53.5% in the DS group and 40.0% in the DD group demonstrating "optimal" compliance.Both intranasal spray and syringe drop methods were highly effective in providing sedation and anxiolysis, but the ready-to-use intranasal dexmedetomidine spray was more acceptable to children, offering a viable alternative to the syringe method.

    Keywords: Atomization, m-YPAS, pediatric, preoperative anxiety, Ramsay sedation scale Clinical Trial Registration: ChiCTR.org.cn, identifier ChiCTR2400089374

    Received: 15 Nov 2024; Accepted: 10 Jan 2025.

    Copyright: © 2025 Jin, Cai, Zhou, Zhang, Chen, Xu, Li and Yuan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Jun Li, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China
    Kai-Ming Yuan, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.