The effect of two different doses of Fentanyl on sedation of infants with respiratory distress syndrome under mechanical ventilation

Comparing the Effect of Different Doses of Fentanyl on Sedation of Infants with respiratory distress syndrome under Mechanical Ventilation; A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017082517413N27

Enrollment

Registered

2017-11-17

Start date

2016-06-01

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: First group: Fentanyl 0.5 mcg/kg as single dose. Intervention 2: Second group: Fentanyl 1 mcg/kg as single dose.

Treatment - Drugs

First group: Fentanyl 0.5 mcg/kg as single dose

Second group: Fentanyl 1 mcg/kg as single dose

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 with respiratory distress syndrome 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
Respiratory rate. Timepoint: before and one hour after intervention. Method of measurement: Respiration count in one minute by nurse.;Arterial Oxygen saturation. Timepoint: before and one hour after intervention. Method of measurement: Pulse Oxymetry.;Duration of hospitalization. Timepoint: Beginning of study to discharge. Method of measurement: Counting hospital stay days.;Duration of Ventilation. Timepoint: After Intervention. Method of measurement: Counting ventilator-dependent days.;Oxygen concentration. Timepoint: before and one hour after intervention. Method of measurement: Mechanical ventilation device.	—

Measure

Time frame

Respiratory rate. Timepoint: before and one hour after intervention. Method of measurement: Respiration count in one minute by nurse.;Arterial Oxygen saturation. Timepoint: before and one hour after intervention. Method of measurement: Pulse Oxymetry.;Duration of hospitalization. Timepoint: Beginning of study to discharge. Method of measurement: Counting hospital stay days.;Duration of Ventilation. Timepoint: After Intervention. Method of measurement: Counting ventilator-dependent days.;Oxygen concentration. Timepoint: before and one hour after intervention. Method of measurement: Mechanical ventilation device.

—

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