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Comparative Study of the Efficacy of Dexmedetomidine Nasal Spray versus Traditional Dexmedetomidine Nasal Drops for Preoperative Sedation in Pediatric Patients

Comparative Study of the Efficacy of Dexmedetomidine Nasal Spray versus Traditional Dexmedetomidine Nasal Drops for Preoperative Sedation in Pediatric Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089374
Enrollment
Unknown
Registered
2024-09-06
Start date
2023-12-19
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

Preoperative Anxiety

Interventions

dexmedetomidine nasal spray group:The children received dexmedetomidine nasal spray according to their body weight (10.5 kg25.5 kg, 4 sprays were given. Each spray contained 15 µg of dexmedetomidine
dexmedetomidine nasal drops group:The children received dexmedetomidine intranasal drops with the dose of 2 µg/kg

Sponsors

Yuying Children's Hospital, the Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Age 2~7 years old,Gender is not limited 2.ASA class I or II. 3.Surgical Removal of Tonsils and Adenoids Under General Anesthesia Is Required. 4.Normal range of BMI; 5.The patient's family agrees and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1.Individuals with Systemic Diseases or Organ Dysfunction 2.Allergic to Dexmedetomidine 3.Individuals with Intellectual Impairment or Cognitive Dysfunction 4.Experienced Respiratory Tract Infection or Obstructive Disease in the Past Week 5.Other reasons that the investigator considers inappropriate to participate in this trial

Design outcomes

Primary

MeasureTime frame
Ramsay sedation score;Time to achieve satisfactory calmness;

Secondary

MeasureTime frame
Induction compliance checklist score;Modified Yale preoperative anxiety scale;Medication Acceptance Rating;parental separation anxiety scale;Wake-up time;Recovery room dwell time;Postoperative misconduct;

Countries

China

Contacts

Public ContactJun Li

Yuying Children's Hospital, the Second Affiliated Hospital of Wenzhou Medical University

lijun0068@163.com+86 138 5779 3807

Outcome results

None listed

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