A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

Phase 3 Completed 159 enrolled Shanghai Hengrui Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2021-11-24
Primary completion: 2022-05-20
Completion: 2022-05-20

Outcome

Met primary endpoint

paper 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). PMID 39242499 ↗

Publications

Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	30 ug	Intranasal
Subject	Dexmedetomidine	Other / unclassified	50 ug	Intranasal

Indications

No indication recorded.