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Safety and efficacy evaluation of S (+) -ketamine for Postoperative acute pain in children after short surgey in perioperative settings: A randomized, active controlled pragmatic clinical trial

Safety and efficacy evaluation of S (+) -ketamine for Postoperative acute pain in children after short surgey in perioperative settings: A randomized, active controlled pragmatic clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065291
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Pediatric surgery

Interventions

Experimental group:S (+) -ketamine 0.5mg/kg
control group:None

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 7 Years

Inclusion criteria

Inclusion criteria: (1) Age <=17 years old, no gender limitation; (2) Urology and general surgery under general anesthesia; (3) ASA classification I-III; (4) the paitient or his/here guardian voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: (1) The expected length of stay was less than 48h; (2) Patients expected to be admitted to ICU after surgery; (3) Patients expected to return to the ward with tracheal catheter after surgery; (4) known allergic to the active ingredients or excipients of S (+) -ketamine hydrochloride injection; (5) patients with severe consciousness disorder or mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and cognitive dysfunction; (6) Children with congenital heart disease and severely underdeveloped growth and development; (7) Patients with any of the following contraindications for ketamine injection: A) patients at serious risk of elevated blood pressure or intracranial pressure; B) patients with high intraocular pressure (glaucoma) or penetrating eye trauma C) Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic blood pressure over 180 mmHg, or resting diastolic blood pressure over 100 mmHg); D) untreated or undertreated hyperthyroidism;

Design outcomes

Primary

MeasureTime frame
The FLACC score in 48h after surgery;

Countries

China

Contacts

Public ContactZeting Qiu

The First Affiliated Hospital of Shantou University Medical College

docqiuzt@foxmial.com+86 13580546462

Outcome results

None listed

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