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The Effectiveness and Safety of Dextromethorphan Hydrobromide Nasal Spray for Pre-Magnetic Resonance Imaging Sedation in Children

The Effectiveness and Safety of Dextromethorphan Hydrobromide Nasal Spray for Pre-Magnetic Resonance Imaging Sedation in Children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090574
Enrollment
Unknown
Registered
2024-10-09
Start date
2024-10-14
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Pre-MRI Sedation

Interventions

experimental group:Subjects were sedated using dexmedetomidine nasal spray
control group:Subjects were sedated by nasal drops of dexmedetomidine hydrochloride injection

Sponsors

Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 2 Years

Inclusion criteria

Inclusion criteria: (1) ASA I-II level; (2) Age 1-2 years old; (3) Children weighing 10-15kg (4) requiring sedation before MRI examination

Exclusion criteria

Exclusion criteria: (1) ASAIII level and above; (2) nasal mucosa injury in children; (3) severe upper respiratory tract infection; (4) dysfunction of liver and kidney; (5) History of sedative drug allergy; (6) Experienced general anesthesia within 2 weeks; (7) Use of sedative hypnotics (including benzodiazepines such as diazepam and barbiturates such as phenobarbital, etc.) within 1 week; (8) mental system diseases and cognitive dysfunction; (9) Arrhythmia, especially chronic arrhythmia; (10) Severe obesity (weight =50% above the standard body weight); (11) follow-up missing; (12) Refuse to participate in this study; (13) Other conditions that the investigator determines are not suitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Sedation time; adverse event;Sedation satisfaction rate;Success rate of rescue sedation;vital signs;recovery time;

Countries

China

Contacts

Public ContactJinjin Huang

Children's Hospital, Zhejiang University, School of Medicine

6196008@zju.edu.cn+86 136 0652 2815

Outcome results

None listed

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