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Unknown statusPhase 4

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

NCT04834427 · Chinese PLA General Hospital

Closed to entry
Status
Not accepting participants
Phase 4
Phase
3,000
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The area under the broken line of FLACC scale score

    Measured over Hour 0-48 after surgery

  • The area under the broken line of Numerical Rating Scale score

    Measured over Hour 0-48 after surgery

  • Opioid consumption

    Measured over Hour 0-48 after surgery

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Age ≤17 years; 2. Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia; 3. ASA physical status I~Ⅲ; 4. The informed consent form was signed by the patients or the guardians. Exclusion Criteria: 1. The expected length of hospital stay of the patient is less than 48h; 2. Patients expected to be admitted to the ICU after surgery; 3. Patients expected to return to the ward with tracheal catheter after surgery; 4. Be allergic to S (+) - ketamine; 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; 6. Patients with congenital heart disease or severely developmental retardation; 7. Patients with any of the following contraindications of S (+) - ketamine: 1. Patients with risk of serious rise of blood pressure or intracranial pressure; 2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; 3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg); 4. Patients with untreated or undertreated hyperthyroidism.

Where

1 study site

FacilityCityRegionCountry
Chinese PLA General HospitalBeijingBeijing MunicipalityChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04834427 on ClinicalTrials.gov →

Last updated in the registry 2024-03-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits