The effectiveness and safety of dexmedetomidine hydrochloride nasal spray for sedation before cardiac catheterization in children with congenital heart disease: a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500097372

Enrollment

Unknown

Registered

2025-02-18

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Cardiac catheterization of congenital heart disease in children

Interventions

Experimental group:Dexmedetomidine nasal spray

Control group:Midazolam nasal drops

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Ages 2 to 6 years old; 2.Children with congenital heart disease who need to undergo scheduled cardiac catheterization. 3.ASA II-III; 4.The individual or their guardian voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients whose parents refuse or do not cooperate; 2.Research on drug allergies; 3.Any nasal disease that may interfere with nasal administration. 4.intellectual dullness; 5.Obstructive laryngeal lesions.

Design outcomes

Primary

Measure	Time frame
Ramsay Score;	—

Secondary

Measure	Time frame
Sedative remedy rate;Adverse event;Guardian satisfaction;	—

Countries

China

Contacts

Public ContactYueyi Ren

Qingdao Women and Children's Hospital

ryyqd@126.com+86 18505321173

Outcome results

None listed

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