Safety and Efficacy Evaluation of S (+) - Ketamine in Children

Phase 4 Unknown 3000 enrolled Chinese PLA General Hospital Beijing Children's Hospital · collab Hunan Children's Hospital · collab Shanghai Children's Medical Center · collab Southern Medical University, China · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.

Timeline

Start: 2022-04-20
Primary completion: 2024-12-01
Completion: 2024-12-04

Publications

Wang H, Duan C, Zhang J, Qu S, Sun Y, Zhou L, Yang L, Lan C, Mi W, Chen P. Evaluation of the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children: study protocol for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic clinical trial. Trials. 2022 Jul 23;23(1):586. doi: 10.1186/s13063-022-06534-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	0.02 mg/kg	Intravenous
Subject	Ketamine	Small molecule	0.1 mg/kg	Intravenous
Subject	Ketamine	Small molecule	0.25 mg/kg	Intravenous
Subject	Ketamine	Small molecule	2 mg/kg	Intravenous
Subject	Ketamine	Small molecule	4 mg/kg	Intravenous

Safety and Efficacy Evaluation of S (+) - Ketamine in Children

Summary

Timeline

Publications

Drugs

Indications