The evaluation of the efficacy and safety of sedation of oral midazolam combination with intranasal dexmedetomidine for magnetic resonance imaging in pediatric patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021847

Enrollment

Unknown

Registered

2019-03-13

Start date

2019-03-15

Completion date

Unknown

Last updated

2020-03-02

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

Conditions

epilepsy

Interventions

Group 1:2µg/kg of intranasal dexmedetomidine with 0·3mg/kg oral midazolam

Group 2:2 µg.kg-1 intranasal dexmedetomidine with 50mg.kg-1 Chloral hydrate

Eligibility

Sex/Gender

All

Age

3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children of ASA physical status 1–3, aged over 36 months scheduled to undergo magnetic resonance image(MRI) will be enrolled in the study

Exclusion criteria

Exclusion criteria: 1. younger than 36 months; 2. allergy or hypersensitivity to experimental agents or ASA physical status >3; 3. cardiac conduction system diseases; 4. accept digoxin or Beta agonists at experimental day; 5. Down syndrome; 6. severe aortic stenosis; 7. acute rhinitis or nasal discharge; 8. accept other sedative drugs in 48 hours; 9. BMI>24.

Design outcomes

Primary

Measure	Time frame
success rate;induction time;recovery time;total sedation time;	—

Countries

China

Contacts

Public ContactJi Yingying

Shanghai Children's Medical Center

278676842@qq.com+86 13816690956

Outcome results

None listed

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