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

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

April 20, 2022

Primary Completion Date

December 1, 2024

Study Completion Date

December 4, 2024

Conditions
S-ketamineEsketamineAcute PainPostoperative PainAnalgesiaHyperalgesiaDeliriumDepression, AnxietyChildren
Interventions
DRUG

Conventional therapy + S (+)-Ketamine

"In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection, but the recommended dosage is given, which is lower than the dosage specified in the instructions.~Recommended use and dosage of S (+)-Ketamine:~1. Intravenous injection:Bolus intravenous injection before skin incision, the dose is 0.1\~0.25 mg/kg; Bolus intravenous injection (dose 0.1\~0.25 mg/kg) before skin incision + continuous intravenous infusion (dose of 0.1\~0.25 mg/kg/h) during operation; Continuous intravenous infusion after surgery with a dose of 0.02\~0.1 mg/kg/h for 24\~48 h.~2. Intramuscular injection:The dose is 2\~4 mg/kg."

DRUG

Conventional therapy

Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.

Trial Locations (1)

Unknown

Chinese PLA General Hospital, Beijing

All Listed Sponsors
collaborator

Southern Medical University, China

OTHER

collaborator

Beijing Children's Hospital

OTHER

collaborator

Shanghai Children's Medical Center

OTHER

collaborator

Hunan Children's Hospital

OTHER_GOV

lead

Chinese PLA General Hospital

OTHER