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Effect of Zolpidem and Midazolam on anxiety of children

Comparison of oral Midazolam with oral Zolpidem on the anxiety of children undergoing eye evaluation under general anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141127020112N7
Enrollment
56
Registered
2018-10-19
Start date
2018-07-27
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Anxiety in children before surgery.

Interventions

Intervention 1: Intervention group 1: 0.25 mg/kg of midazolam
30 minutes before surgery. Intervention 2: Intervention group 2: 0.25 mg/kg of zolpidem
30 minutes before surgery.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 9 Years

Inclusion criteria

Inclusion criteria: Pediatric patients ages 2-9 years ASA class I-II undergoing eye evaluation under general anesthesia

Exclusion criteria

Exclusion criteria: contraindication to preoperative sedation, known allergy or sensitivity to the study medications parents' unwillingness on the children's participation in the study Patients with weights below the 5th percentile or above the 95th percentile according to the current published CDC growth chart Children with metabolic, endocrine, cardiac, pulmonary or hepatic diseases

Design outcomes

Primary

MeasureTime frame
Anxiety score. Timepoint: Measuring the anxiety level at the beginning of the study (before the intervention) and thirty minutes after taking the drug. Method of measurement: Modified Yale preoperative anxiety scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPooya derakhshan

Iran University of Medical Sciences

pooya_derakhshan@bums.ac.ir+98 56 3234 1410

Outcome results

None listed

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