Comparison of Midazolam and Fentanyl for sedation of infants under mechanical ventilation

Comparing the effect of Fentanyl and Midazolam on the Sedation of infants under mechanical ventilation; A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017082417413N26

Enrollment

Registered

2017-09-02

Start date

2016-07-01

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

Respiratory distress syndrome of newborn. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Second group: Fentanyl 0.5 mcg/kg. Intervention 2: First group: Midazolam 0.1 mg/kg.

Treatment - Drugs

Second group: Fentanyl 0.5 mcg/kg

First group: Midazolam 0.1 mg/kg

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Infants between 2.5 and 4 kg of weight who needed intubation and mechanical ventilation Exclusion criteria: Patients lower than 2.5 kg and more than 4 kg; congenital heart disease; brain anomalies; metabolic or chromosomal syndromes

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of hospitalization. Timepoint: After Intervention. Method of measurement: Counting hospital stay days.;Duration of Ventilation. Timepoint: After Intervention. Method of measurement: Counting ventilator-dependent days.	—

Secondary

Measure	Time frame
Pneumothorax. Timepoint: After Intervention. Method of measurement: Plain chest X-ray.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Khosravi

Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran

dr.mhkhosravi@gmail.com+98 21 8862 0826

Outcome results

None listed

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