Observational study of the effect of perioperative intravenous infusion of low-dose esketamine on postoperative pain in pediatric surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073879

Enrollment

Unknown

Registered

2023-07-24

Start date

2023-01-06

Completion date

Unknown

Last updated

2023-07-30

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

Conditions

pediatric urology

Interventions

Esketamine group 1:Esketamine 0.3 mg/kg before anesthesia induction Esketamine 1.0 mg/kg + hydromorphone 0.1 mg/kg + normal saline diluted to 100 ml in the analgesic pump

Eesketamine group 2:Equal amount of saline before induction of anesthesia Esketamine 1.0 mg/kg + hydromorphone 0.1 mg/kg + normal saline diluted to 100 ml in the analgesic pump

Hydromorphone group 1:Equal amount of saline before induction of anesthesia Hydromorphone 0.1 mg/kg + normal saline diluted to 100 ml in the analgesic pump

Hydromorphone group 2:Equal amount of saline before induction of anesthesia Hydromorphone 0.15mg/kg + normal saline diluted to 100 ml in the analgesic pump

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: ? Children were aged 2-12 years ? ASA grade as I or II ? Children with a perioperative intravenous infusion of a small dose of esketamine ? PCA analgesic pump was used after the surgery ? The parents gave informed consent ? Body weight is within ± 10% of the standard body weight

Exclusion criteria

Exclusion criteria: ? Patients with serious organic diseases such as heart, liver and kidney ? Have mental, neurological diseases can not cooperate ? Patients with a history of chronic pain or analgesic medication ? A history of anesthetic drug allergy or bronchial asthma disease ? Patients with a history of acute upper respiratory tract infection within two weeks before surgery

Design outcomes

Primary

Measure	Time frame
FLACC or NRS scores of pain levels in children 2h, 6h, 24h and 48h after surgery;	—

Secondary

Measure	Time frame
The cumulative hydromorphone consumption in children 2h, 6h, 24h and 48h after surgery;The Ramsay sedation score in the children 2h, 6h, 24h and 48h after surgery;Perioperative remifentanil consumption;Chocough and agitation when removing the laryngeal mask;Adverse reactions such as nausea, vomiting, skin itching, headache, dizziness, drowsiness, hallucinations, irritability, respiratory depression, etc;PCA first compression time, total and effective number of compressions after awakening;Number of remedial analgesia and antiemesis;Extubation time;wake up time;	—

Measure

Time frame

The cumulative hydromorphone consumption in children 2h, 6h, 24h and 48h after surgery;The Ramsay sedation score in the children 2h, 6h, 24h and 48h after surgery;Perioperative remifentanil consumption;Chocough and agitation when removing the laryngeal mask;Adverse reactions such as nausea, vomiting, skin itching, headache, dizziness, drowsiness, hallucinations, irritability, respiratory depression, etc;PCA first compression time, total and effective number of compressions after awakening;Number of remedial analgesia and antiemesis;Extubation time;wake up time;

—

Countries

China

Contacts

Public ContactJingjing Yuan

The First Affiliated Hospital of Zhengzhou University

yjingjing_99@163.com+86 135 1371 9631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026