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Clinical study of oral esketamine for premedication on perioperative comfort of children

Clinical study of oral esketamine for premedication on perioperative comfort of children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044974
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-04-10
Completion date
Unknown
Last updated
2021-11-02

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

Conditions

Preanaesthetic medication in children

Interventions

BC group:Oral administration of 10% glucose 0.2 mL /kg
EK1 group:Oral administration of 1mg/kg ketamine and 0.2 mL /kg glucose with a final concentration of 10%
EK2 group:Oral administration of 2mg/kg ketamine and 0.2 mL /kg glucose with a final concentration of 10%
EK3 group:Oral administration of 3mg/kg ketamine and 0.2 mL /kg glucose with a final concentration of 10%

Sponsors

Liaocheng People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children undergoing elective surgery for ENT tonsillectomy and adenoidectomy in our hospital from April 2021 to December 2022. 2. Aged 1-6 years, with a BMI of 18-27kg/m^2, ASA grade 1-2. 3. No history of congenital genetic and mental retardation, serious systemic diseases, liver and kidney insufficiency, and opioid abuse.

Exclusion criteria

Exclusion criteria: 1. Preoperative assessment of difficult airway; 2. Upper respiratory tract infection within a week of history

Design outcomes

Primary

MeasureTime frame
Acceptability of oral medication in the child;Score and acceptance rate of parent-child separation;Analgesia score and acceptance rate of intravenous catheterization;Intraoperative dosage of remifentanil;Sedation score during awakening period;Dosage of postoperative analgesics;

Secondary

MeasureTime frame
Ntraoperative period, preoperative period, intraoperative period and postoperative period of recovery, vital signs indicators;Sedation and mood state scores at 5, 10, 15, 20, 25, 30 minutes before and after medication;The onset time of the drug;Time of parent-child separation;Venipuncture time;Respiratory depression and complications occurred before and during recovery;Number of cases of anticholinergic drug use;Duration of anesthesia recovery room;Number of cases of postoperative nausea and vomiting;Number of abnormal mental behavior after operation;Postoperative hospital stay time;Anesthesia satisfaction score of perioperative medical care and family members;

Countries

China

Contacts

Public ContactLiu Zunyuan

Liaocheng People's Hospital

ly29.love@163.com+86 18263511977

Outcome results

None listed

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