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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 (SAFE-SK-C)

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 (SAFE-SK-C)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081040
Enrollment
Unknown
Registered
2024-02-21
Start date
2024-03-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopaedics

Interventions

Group A:S (+) -ketamine was used during the perioperative period
Group C:S (+) -ketamine was not used during the perioperative period

Sponsors

Municipality Hospital of Jinjiang(Shanghai Sixth People's Hospital Fujian Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Age <= 17 years old 2.Elective orthopaedic surgery under general anesthesia 3.ASA?~? 4.The patient's guardian voluntarily signed an informed consent form

Exclusion criteria

Exclusion criteria: 1:   1.The expected length of stay was less than 48 hours 2.Patients expected to enter the ICU postoperatively 3.The patient was expected to return to the ward with a tracheal catheter 4.Allergic to the active ingredients or excipients of S (+) -ketamine 5.Severe disturbance of consciousness or psychosis or Cognitive impairment 6.Congenital heart defect and the growth is seriously backward children 7.Patients with contraindications to the use of S (+) -ketamine injection 1) High intracranial pressure 2)High intraocular pressure,Glaucoma,Penetrating ocular trauma 3)High blood pressure 4)Hyperthyroidism

Design outcomes

Primary

MeasureTime frame
FLACC pain score;Opioid dosage;

Secondary

MeasureTime frame
Time to first salvage analgesic use after surgery;Incidence of salvage analgesia within 48 hours after surgery;Time of anesthesia recovery;Incidence of delirium in awakening period;Incidence of intraoperative adverse events;Incidence of postoperative adverse events;Pharmacoeconomic indicators;

Countries

china

Contacts

Public ContactLIN Jianshui

Municipality Hospital of Jinjiang(Shanghai Sixth People's Hospital Fujian Hospital)

jslin98@163.com+86 135 5959 3036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026