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?
| ISRCTN | ISRCTN33764131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33764131 |
| Sponsor | Onassis Hospital |
| Funder | Alexander S. Onassis Public Benefit Foundation |
- Submission date
- 05/04/2026
- Registration date
- 09/04/2026
- Last edited
- 09/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The study aims to assess the safety and effectiveness of two different routes of administration of midazolam as premedication for children with congenital heart disease allocated to receive general anesthesia in the theatre or cath lab.
Who can participate?
Children aged 6 months to 8 years with heart disease allocated to receive general anesthesia
What does the study involve?
Participants are randomly allocated to receive midazolam as premedication either by mouth or under the tongue. Midazolam concentration is measured in blood samples 30 min after intake, along with blood pressure, heart rate, oxygen saturation, sedation, separation from parents, and mask acceptance.
What are the possible benefits and risks of participating?
The benefits of premedication before anesthesia are to reduce preoperative anxiety and fear and to improve anesthesia induction. Children with congenital heart problems usually undergo interventions in the operating theater or cath lab more than one time so they might be more difficult to handle due to their prior experience. They even sometimes refuse to swallow the premed and that has led us to compare an alternative route of administration, the sublingual, that requires less cooperation from the child. Even though premedication of pediatric patients with midazolam is a standard procedure in our hospital, we are aware and alert in case of possible risks such as respiratory depression, oversedation or cardiovascular effects, especially in the vulnerable pediatric cardiac population.
Where is the study run from?
Onassis Hospital (Greece)
When is the study starting and how long is it expected to run for?
July 2021 to October 2022
Who is funding the study?
Alexander S. Onassis Public Benefit Foundation (Greece)
Who is the main contact?
Theofili Kousi, t.kousi@onasseio.gr
Contact information
Principal investigator, Scientific, Public
Leoforos Syngrou 356, Kallithea
Athens
17674
Greece
 ORCID ID |
0000-0001-6515-1836 |
|---|---|
| Phone | +30 (0)6944635346 |
| t.kousi@onasseio.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Basic science, Treatment |
| Scientific title | Oral versus sublingual midazolam premedication in pediatric cardiac population: pharmacokinetic, hemodynamic, and behavioral outcomes |
| Study objectives | Dose- and age-adjusted pharmacokinetic models; age- and weight-adjusted hemodynamic models; Fisher exact tests for behavioral outcomes. |
| Ethics approval(s) |
Approved 05/03/2021, Ethics Committee Onassis Cardiac Surgery Center (Onasseio Nosokomeio, 356 Leoforos Syngrou, Athens, 17674, Greece; +30 (0)2109493374; a.gkouvelou@onasseio.gr), ref: B.03. Π.Ε.Ε 709 (ΙΩ Γ 010) / 25.02.2021 |
| Health condition(s) or problem(s) studied | Pediatric cardiac surgery or cardiological intervention in the cath lab with general anaesthesia, requiring premedication |
| Intervention | Children receiving preoperative midazolam as premedication before cardiac surgery or cath lab intervention. Patients were classified according to administration route: oral (Σ) or sublingual (Υ). The dataset contained 68 children in total (33 oral and 35 sublingual). Date of birth was used to estimate age in years with 2021 as the study year; age was calculated relative to 01/07/2021 for analytic consistency. Oral treatment group (Σ): Generic drug name: midazolam Dosage: 0.5 mg/kg Method: oral route, by mouth Frequency of administration: once Total duration and follow-up: 30 minutes sublingual treatment group (Y) Generic drug name: midazolam Dosage: 0.3 mg/kg Method: sublingual, under the tongue Frequency of administration: once Total duration and follow-up: 30 minutes Randomisation process: computer-generated random numbers |
| Intervention type | Drug |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Midazolam |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 03/10/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 8 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 65 |
| Key inclusion criteria | 1. Pediatric congenital population 2. Programmed intervention in operation theater or cath lab 3. General anaesthesia required |
| Key exclusion criteria | 1. Age below 6 months 2. Weight below 5 kg 3. Weight above 40 kg |
| Date of first enrolment | 14/07/2021 |
| Date of final enrolment | 02/10/2022 |
Locations
Countries of recruitment
- Greece
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
07/04/2026: Study's existence confirmed by the Ethics Committee Onassis Cardiac Surgery Center.
