Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04834427
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-08
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of S (+) - Ketamine in Children
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
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:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: