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

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.

Conditions

• S-ketamine
• Esketamine
• Acute Pain
• Postoperative Pain
• Analgesia
• Hyperalgesia
• Delirium
• Depression, Anxiety
• Children

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.

Sponsors & Collaborators

• Southern Medical University, China

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Weidong Mi, MD · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-20

Primary Completion

2024-12-01

Completion

2024-12-04

Countries

• China

Study Locations