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Comparing the effects of oral midazolam, and chloral hydrate on sedation of children before echocardiography: A clinical trial

Comparing the effects of oral midazolam, and chloral hydrate on sedation of children before echocardiography: A clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017042317756N13
Enrollment
45
Registered
2017-05-04
Start date
2017-05-06
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Effect of sedative drugs. Sedatives, hypnotics and antianxiety drugs

Interventions

Intervention 1: The first intervention group: 0.2 milligram per kilogram oral midazolam administered once. Intervention 2: The second intervention group: 0.1 milligram per kilogram intravenous midazol
Treatment - Drugs
The first intervention group: 0.2 milligram per kilogram oral midazolam administered once
The second intervention group: 0.1 milligram per kilogram intravenous midazolam
The third intervention group: 50 mg per kg chloral hydrate syrup administered orally once

Sponsors

Vice-chancellor for Research, Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 12 Years

Inclusion criteria

Inclusion criteria: 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 ICU

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Ebrahimzadeh

Birjand University of Medical Sciences

ebrahimzadehali@yahoo.com+98 56 3239 1200

Outcome results

None listed

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