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

Phase 4 Unknown 12000 enrolled Chinese PLA General Hospital Beijing Hospital · collab First Affiliated Hospital Xi'an Jiaotong University · collab First Affiliated Hospital, Sun Yat-Sen University · collab Jiangsu Provincial People's Hospital · collab Renmin Hospital of Wuhan University · collab Shengjing Hospital · collab Southern Medical University, China · collab The Affiliated Hospital of Qingdao University · 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 adults in perioperative settings.

Timeline

Start: 2021-05-01
Primary completion: 2022-06-01
Completion: 2022-06-30

Publications

Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681.

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	0.5 mg/kg	Intravenous

Indications

No indication recorded.