Two ways to give a calming medicine to children with heart disease before submitting them to anesthesia for cardiac surgery or catheterization. Which works better for them?

Oral versus sublingual midazolam premedication in pediatric cardiac population: pharmacokinetic, hemodynamic, and behavioral outcomes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33764131

Enrollment

Registered

2026-04-09

Start date

2021-07-14

Completion date

Unknown

Last updated

2026-04-20

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

Conditions

Pediatric cardiac surgery or cardiological intervention in the cath lab with general anaesthesia, requiring premedication Circulatory System

Interventions

Children receiving preoperative midazolam as premedication before cardiac surgery or cath lab intervention. Patients were classified according to administration route: oral (S) or sublingual (?). The

age was calculated relative to 01/07/2021 for analytic consistency. Oral treatment group (S): Generic drug name: midazolam Dosage: 0.5 mg/kg Method: oral route, by mouth Frequency of administration:

Eligibility

Sex/Gender

All

Age

6 Months to 8 Years

Inclusion criteria

Inclusion criteria: 1. Pediatric congenital population 2. Programmed intervention in operation theater or cath lab 3. General anaesthesia required

Exclusion criteria

Exclusion criteria: 1. Age below 6 months 2. Weight below 5 kg 3. Weight above 40 kg

Countries

Greece

Contacts

Public ContactTheofili Kousi

t.kousi@onasseio.gr+30 (0)6944635346

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026