NCT04834427

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

Safety and Efficacy Evaluation of S (+) -Ketamine for Postoperative Acute Pain in Children in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children often suffer acute pain,awakening delirium, anxiety and depression after operation which may affect the recovery of children. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese children undergoing surgery. Objective: To evaluate the analgesic effect of perioperative administration of S (+) - ketamine on postoperative acute pain in children undergoing surgery, and explore the effects of S (+) - ketamine on postoperative awakening delirium, postoperative anxiety and depression mood ,as well find the best usage, including dose, timing, compatibility, and type of operation.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-20
• Primary completion: 2024-12-01
• Completion: 2024-12-04
• First posted: 2021-04-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: China