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A study on the sedation of ED95 in outpatient pediatric patients undergoing magnetic resonance examination using oral midazolam solution combined with dexmedetomidine nasal drops

A study on the sedation of ED95 in outpatient pediatric patients undergoing magnetic resonance examination using oral midazolam solution combined with dexmedetomidine nasal drops

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126416
Enrollment
Unknown
Registered
2026-06-09
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

None

Interventions

Experimental group:Oral administration of midazolam solution combined with nasal drops of dexmedetomidine

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 magnetic resonance imaging (MRI) examination of a single area with a total examination time of no more than 15 minutes; 2. Age 1-6 years old, gender not restricted; ASA rating I-II; 3. Normal nasal mucosa, without inflammation, injury, nasal congestion or other conditions that affect drug absorption; 4. The legal guardian of the child is willing to participate in this study and signs the informed consent form, being aware of the relevant compensation and insurance policies of the study.

Exclusion criteria

Exclusion criteria: 1. Allergic to the studied drug; 2. Suffering from systemic diseases with severe organ dysfunction; 3. Having inflammatory conditions, mucosal erosion/injury, nasal congestion, nasal polyps, etc. that affect the absorption of drugs in the nasal mucosa; 4. Having a history of intellectual disability or cognitive impairment and being unable to cooperate; 5. The guardian refuses to participate in the study; 6. Other reasons as deemed by the researcher that make further treatment impossible.

Design outcomes

Primary

MeasureTime frame
Success rate of magnetic resonance examination;

Secondary

MeasureTime frame
Children's behavior scores at the time of drug administration;Modified Ramsay sedation score at the beginning of examination;The time from taking the medicine to achieving satisfactory sedation and initiating the examination (T1);Whether remedial sedation has occurred;Inspection time (T2);Parent satisfaction;Awakening time (T3, the time from the end of the examination to the child's spontaneous opening of eyes);

Countries

China

Contacts

Public ContactHongfei Xiong

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: Jun 21, 2026