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Effects of different doses of Esketamine on restlessness during recovery period of tonsillectomy in children

Effects of different doses of Esketamine on restlessness during recovery period of tonsillectomy in children

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075038
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Hypertrophy of tonsil in children

Interventions

Group K3:Esketamine 0.5mg/kg
Group K1:Esketamine 0.1mg/kg
Group K2:Esketamine 0.3mg/kg
Group K0:Esketamine 0mg/kg

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: A total of 164 children with tonsil or adenoid hypertrophy aged 3 ~ 10 years were included. BMI 18-28 kg/m2; ASA grade ?-?; Preoperative physical examination showed no abnormality in cardiopulmonary function and normal liver and kidney function.

Exclusion criteria

Exclusion criteria: Patients who had emergency surgery, a history of allergy to opioid or non-opioid analgesics, a history of respiratory infection or asthma, developmental delays or psychiatric disorders associated with symptoms such as irritability, anxiety, attention deficit, sleep disturbance, or cognitive impairment, children who had difficulty with the preoperative assessment, or were unable to complete the trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Agitation Score (PAED Score);Agitation Score (Watcha Score);Heart rate;Systolic blood pressure;

Secondary

MeasureTime frame
Calm score (Ramsay score);The duration and frequency of postoperative agitation;

Countries

China

Contacts

Public ContactPingPing Jiang

Affiliated Hospital of North Sichuan Medical College

307174907@qq.com+86 158 8149 6034

Outcome results

None listed

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