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Melatonin supplementation and midazolam reduction

Investigating the effect of oral melatonin compared to placeto in the required dose of venous midazolam in children under mechanical ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240518061831N1
Enrollment
44
Registered
2024-07-09
Start date
2024-06-19
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Intubated children. Encounter for newborn, infant and child health examinations

Interventions

Intervention 1: Intervention group: midazolam infusion at the rate of 0.1-0.5 mg/kg/hours and fentanyl at the rate of 1-5 mac/kg/hours and melatonin 3 mg dissolved in DW 5%? orally through NGT. Interv

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 12 Years

Inclusion criteria

Inclusion criteria: Children under ventilator from 3 months to 12 years At the first week of hospitalization

Exclusion criteria

Exclusion criteria: Need for continuous infusion of muscle relaxants The need to receive midazolam and fentanyl less or more than the listed doses based on the score Sedation Mechanical ventilation more than one week NPO more than one week liver and kidney disorder Glasgow Score less than 8 at the study entry

Design outcomes

Primary

MeasureTime frame
Intravenous midazolam continuous infusion dose. Timepoint: at the baseline and one week later. Method of measurement: Dose of Midazolam based on mg/kg/hr.

Secondary

MeasureTime frame
Dose of interavenous opioid. Timepoint: at the baseline and one week later. Method of measurement: Dose of opioid drug based on µg/ kg/hr.;Patient's sedation score. Timepoint: at the baseline and one week later. Method of measurement: State Behavioral Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyedeh Narjes Ahmadizadeh

Shahid Beheshti University of Medical Sciences

Dr.nahmadizadeh@sbmu.ac.ir+98 21 2712 3850

Outcome results

None listed

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