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Babysed in children sedation

Evaluation of the efficacy and safety of babysed versus chloral hydrate in children under six years old before echocardiography: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200202046335N2
Enrollment
30
Registered
2020-09-13
Start date
2019-08-06
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

sadation. Circadian rhythm sleep disorders

Interventions

Intervention 1: Control group: In this group, half hour before echocardiography, chlorate hydrate (oral drop100g/ml, prepared in pharmacy) is prescribed at a single dose of 50 mg /kg per oral. If the

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 6 Years

Inclusion criteria

Inclusion criteria: children 2 months to 6 years old are candidate for echocardiography who need sedation.

Exclusion criteria

Exclusion criteria: children with respiratory problems allergy to chloral hydrate allergy to babysed ingredients children with abnormal breathing when referred receive sedative medication in last 48 hours

Design outcomes

Primary

MeasureTime frame
Depth of sleep. Timepoint: assess the depth of sleep for half hour to an hour after prescribing the drug and then every 15 minutes. Method of measurement: The Ramsay sedation scale criteria is used to check the depth of sleep.;Sleep duration. Timepoint: assess the duration of sleep for half hour to an hour after prescribing the drug and then every 15 minutes. Method of measurement: The duration of sleep is also recorded in minutes and by observing the child.

Secondary

MeasureTime frame
Medication adverse effects. Timepoint: From the time of drug administration until 24 hours later. Method of measurement: In case of symptoms such as shortness of breath, dermatitis in hypersensitive people, allergic reaction and anaphylaxis, abdominal pain, dizziness and wheezing are examined and recorded according to the Naranjo algorithm.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Lida Shojaei

Kermanshah University of Medical Sciences

shojaeilida96@yahoo.com083

Outcome results

None listed

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