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Comparison of remifentanil besylate and dexmedetomidine nasal drops for sedation in pediatric fracture surgery

Comparison of remifentanil besylate and dexmedetomidine nasal drops for sedation in pediatric fracture surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111916
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Childhood fracture disease

Interventions

Rimazolen benzenesulfonate group (R group):Rimazolen Besylate 1.5 mg/kg Nasal Drops
Dexmedetomidine group (D group):Dexmedetomidine 2 µ g/kg nasal drops

Sponsors

The Second Affiliated Hospital of Inner Mongolia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children with upper or lower limb fractures who are scheduled for surgical treatment; Age: 1-6 years old; ASA classification: I~II.

Exclusion criteria

Exclusion criteria: Abnormal or malformed nasal cavity; Allergic to remifentanil besylate or dexmedetomidine; Upper respiratory tract infection in the past two weeks; Asthma; Heart conduction block; Individuals with contraindications to sedation or anesthesia No informed consent

Design outcomes

Primary

MeasureTime frame
Improved alertness/sedation score;Sedation onset time;Number of cases of remedial sedation;Sedation duration;

Secondary

MeasureTime frame
Satisfaction of the surgeon and family members with the sedation of the patient;adverse reaction;

Countries

China

Contacts

Public ContactLi Yating

The Second Affiliated Hospital of Inner Mongolia Medical University

471668643@qq.com+86 153 5488 9303

Outcome results

None listed

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