Comparing the effects of oral midazolam, and chloral hydrate on sedation of children before echocardiography: A clinical trial
Phase 2
Recruiting
- Conditions
- Effect of sedative drugs.Sedatives, hypnotics and antianxiety drugs
- Registration Number
- IRCT2017042317756N13
- Lead Sponsor
- Vice-chancellor for Research, Birjand University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
age below 12 years; alertness; no respirational distress; no hypotonia.
Exclusion criteria: Non-cooperative infant or child despite the use of the sedative where echocardiography cannot be performed (uncooperative patient); uncooperative parents because of side effects of the drug; instability of the patient after taking the drug where s/he needs to be hospitalized in the IC
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of sedation. Timepoint: At the time of sleepiness of the patient. Method of measurement: Richmond Agitation-Sedation Score.;Onset of sedative effect. Timepoint: Every 2 minutes from drug prescription until sleepiness. Method of measurement: observation.;Duration of sedative effect. Timepoint: Every 5 minutes from sleepiness onset until total alertness. Method of measurement: Observation.
- Secondary Outcome Measures
Name Time Method Gestational complications (including nausea and vomitting). Timepoint: From drug administration for an hour. Method of measurement: Observation.;Respirational complications (Apnea). Timepoint: From drug administration for an hour. Method of measurement: Observation.;Nervous complications (Agitation). Timepoint: From drug administration for an hour. Method of measurement: Observation.