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Effectiveness of the chloral hydrate in children

Investigating the sedation effect of new chloral hydrate formulation in comparison with common formulations in children under diagnostic procedures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240630062282N1
Enrollment
110
Registered
2024-10-04
Start date
2024-08-09
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Sedation of uncooperative children in medical examinations.

Interventions

Intervention 1: Intervention group: In the intervention group, chloral hydrate with the researcher's formulation is prescribed for children. Intervention 2: Control group: in the control group, chlora

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 6 Years

Inclusion criteria

Inclusion criteria: All outpatients or inpatients at Dr. Mohammad Kermanshahi Hospital who need diagnostic procedures

Exclusion criteria

Exclusion criteria: Background brain diseases Dissatisfaction of parents

Design outcomes

Primary

MeasureTime frame
The time of taking the medicine until falling asleep and from the time of falling asleep until the child wakes up is recorded by the doctor. After the child regains consciousness, complications such as breathing problems, QT interval in the ECG, nausea, diarrhea, vomiting, confusion and restlessness caused by the use of the drug are checked for the next day. Timepoint: After the child regains consciousness, complications such as breathing problems, QT interval in the ECG, nausea, diarrhea, vomiting, confusion and restlessness caused by the use of the drug are checked for the next day. Method of measurement: Measurements are made with a researcher-made checklist.

Secondary

MeasureTime frame
The main consequence of the drug is the lack of proper cooperation of the child due to the unpleasant taste of the current homemade solutions and digestive irritations during the continued use of the drug. Timepoint: Relaxation is done by the researcher. Then all clinical signs are checked for the next day. Method of measurement: The measurement tool is a researcher-made checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPouria Moradi

Kermanshah University of Medical Sciences

poria.pediatrics@gmail.com+98 83 3725 2563

Outcome results

None listed

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