Babysed in children sedatio

Phase 3

• Conditions: sadation.; Circadian rhythm sleep disorders; G47.2

• Registration Number: IRCT20200202046335N2
• Lead Sponsor: Kermanshah University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.