Pediatric Separation Anxiety
Conditions
Interventions
75% midazolam oral solution + 25% esketamine oral group:75% midazolam oral solution + 25% esketamine mixture orally
50% midazolam oral solution + 50% esketamine oral group:50% midazolam oral solution + 50% esketamine mixture orally
25% midazolam oral solution + 75% esketamine oral group:25% midazolam oral solution + 75% esketamine mixture orally
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Children undergoing surgery; 2. Aged 1-6 years, gender is not limited; 3. ASA rating I-II; 4. The legal guardians of the children are willing to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Malnourished or obese children; 2. Cushing's syndrome, pituitary tumor, adrenal tumors such as endocrine system diseases; 3. Severe respiratory diseases (obstructive sleep apnea syndrome, acute respiratory tract infection, uncontrolled asthma, active massive hemoptysis, pulmonary hypertension, etc.); 4. Any congenital heart disease, acute heart failure, atrioventricular block, or severe arrhythmia; 5. Infectious heart disease such as myocarditis or endocarditis; Sepsis; Pneumonia; 6. Paients suffering from mental system diseases (autism, ADHD, schizophrenia), abnormal brain development and cognitive dysfunction; 7. Anemia or thrombocytopenia: HbULN+3s and/or APTT>ULN+10s); 9. Abnormal liver function: AST and/or ALT>=2.5xULN, TBIL>=1.5xULN; 10. Abnormal renal function: urea or urea nitrogen >=1.5xULN, blood creatinine greater than the upper limit of normal value; 11. Patients whose blood glucose was not satisfactorily controlled (random blood glucose >=11.1mmol/L during the screening period); 12. Allergic or contraindicated to benzodiazepines, opiates, etomidate, propofol, ketamine and other drugs and their components; 13. Patients judged to have difficulty managing the respiratory tract (modified Markov score level ?); 14. Participated in any clinical drug trial as a subject and used the test drug within the last 3 months; 15. Take monoamine oxidase inhibitors for 2 weeks; 16. Taking sedative drugs, antiemetic drugs, motion sickness drugs and anti-pruritus drugs within 48 hours before surgery; 17. Other factors that might interfere with the results of the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Separation Anxiety Score from Parents(PSAS);Mask Induction Acceptance Score;Modified Ramsay Sedation Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's behavior scores at the time of drug administration;Children's modified sedation Ramsay score every 5 minutes after taking the drug;Whether remedial sedation has occurred;Parent satisfaction; | — |
Countries
China
Contacts
Public ContactXiong Hongfei
Xi'an International Medical Center Hospital
Outcome results
None listed