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Comparison of oral midazolam solution and dexmedetomidine nasal drops in pediatric sedation

Study on the application of midazolam oral solution in pediatric anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089247
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-09-18
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Pediatric Separation Anxiety

Interventions

Oral midazolam solution group:Oral Midazolam Oral Solution
Dexmedetomidine Nasal Drops:Dexmedetomidine nasal drops

Sponsors

Xi'an International Medical Center Hospital
Lead Sponsor

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

MeasureTime frame
Separation Anxiety Score from Parents(PSAS);Mask Induction Acceptance Score;

Secondary

MeasureTime 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;Adverse reactions during induction and recovery;

Countries

China

Contacts

Public ContactXiong Hongfei

Xi'an International Medical Center Hospital

bear_0320@163.com+86 185 0290 4320

Outcome results

None listed

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