Status:
ENROLLING_BY_INVITATION
Safety and Efficacy Evaluation of S (+) - Ketamine in Children
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
Southern Medical University, China
Beijing Children's Hospital
Conditions:
S-ketamine
Esketamine
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
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 se...
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 op...
Eligibility Criteria
Inclusion
- Age ≤17 years;
- Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;
- ASA physical status I～Ⅲ;
- The informed consent form was signed by the patients or the guardians.
Exclusion
- The expected length of hospital stay of the patient is less than 48h;
- Patients expected to be admitted to the ICU after surgery;
- Patients expected to return to the ward with tracheal catheter after surgery;
- Be allergic to S (+) - ketamine;
- Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- Patients with congenital heart disease or severely developmental retardation;
- Patients with any of the following contraindications of S (+) - ketamine:
- Patients with risk of serious rise of blood pressure or intracranial pressure;
- Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
- Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
- Patients with untreated or undertreated hyperthyroidism.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2024
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04834427
Start Date
April 20 2022
End Date
December 4 2024
Last Update
March 8 2024
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China