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Safety and efficacy of dexmedetomidine hydrochloride nasal spray combined with midazolam oral solution for MRI or CT in children: a randomized controlled study

Safety and efficacy of dexmedetomidine hydrochloride nasal spray combined with midazolam oral solution for MRI or CT in children: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099766
Enrollment
Unknown
Registered
2025-03-28
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Preoperative anxiety and fear

Interventions

Sponsors

People's Hospital of Leshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.2<=age<=6 years of age with CT or MRI, regardless of gender; 2. ASA score of I-II; 3.15.5 kg/m^2<=BMI<17kg/m^2; 4. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Children with respiratory tract management difficulties (modified Markov Level III); 2.Children with intellectual disabilities; 3.Allergic or contraindicated to dexmedetomidine hydrochloride and its drug components, midazolam or chloral hydrate; 4.The child was not suitable for nasal administration or could not receive nasal administration; 5.Other conditions deemed inappropriate by the investigator (e.g. fever, acute upper respiratory tract infection, etc.).

Design outcomes

Primary

MeasureTime frame
Success rate of sedation of dexmedetomidine hydrochloride nasal spray combined with midazolam oral liquid in children on MRI or CT;

Secondary

MeasureTime frame
Complication rate, including (respiratory depression, hypoxemia, nausea, vomiting, etc.);Comparison of sedation success rate between two groups;Time of onset of sedation;The recovery time after examination;

Countries

China

Contacts

Public ContactLiang Jin

People's Hospital of Leshan

xzmzjl2828@163.com+86 833 2119359

Outcome results

None listed

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