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A comparative study of the effects of intravenous propofol and midazolam premedication on sedation level before surgery in pediatrics

A comparative study of the effects of intravenous propofol and midazolam premedication on sedation level before surgery in pediatrics

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130311012782N65
Enrollment
80
Registered
2026-01-29
Start date
2026-04-04
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Surgery.

Interventions

Intervention 1: Intervention group: Recipient of 0.1 mg/kg intravenous midazolam upon entry to the operating room. Intervention 2: Intervention group: Recipient of 1 mg/kg ketamine and 1 mg/kg propofo

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 6 Years

Inclusion criteria

Inclusion criteria: Age between 6 months to 6 years ASA 1 & II No mental, neurological, or cardiac diseases Written parental consent to participate in the study Elective surgery

Exclusion criteria

Exclusion criteria: Allergic reaction to medications Lack of cooperation between parent or child Use of psychotropic drugs in the past week based on parental history

Design outcomes

Primary

MeasureTime frame
The child's anxiety level before the operation. Timepoint: 1 and 5 minutes after receiving the drug. Method of measurement: m-YPAS score.

Secondary

MeasureTime frame
Blood pressure. Timepoint: 1 and 5 minutes after receiving the drug And upon entering recovery. Method of measurement: Children's blood pressure monitor.;Heart rate. Timepoint: 1 and 5 minutes after drug injection And upon entering recovery. Method of measurement: Cardiac monitoring device.;Drug complications. Timepoint: During the operation and recovery. Method of measurement: Clinical observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Ali Hesamzadeh

Esfahan University of Medical Sciences

ali.hesamzadeh@gmail.com+98 31 3669 2174

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026