Efficacy and Safety of Fentanyl for Pain Control in Newborn on Mechanical Ventilation

Phase 4

• Conditions: Mechanical Ventilation Complication
• Interventions: Drug: Fentanyl

• Registration Number: NCT04937946
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

The purpose of the study is to assess the efficacy and safety of Fentanyl for pain control in Newborns on mechanical ventilator.

Detailed Description

This Randomized Controlled Trial will be conducted in the Department of Neonatology, BSMMU, Dhaka after approval by Institutional Review Board (IRB). A Written informed consent will be obtained before enrollment in the study from the parents or guardians. . The study cohort will comprise all inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who receive mechanical ventilation administered through an endotracheal tube . The enrolled neonates will be randomly assigned with computer-generated random number tables via software named 'Random Allocation Software', to receive either of the intervention.

Once the parents will agree to the study and provide signed informed consent, all eligible neonates will be randomized to start treatment within 24 hours from the initiation of mechanical ventilation. Randomized infants will be allocated to the fentanyl group to receive a continuous infusion of fentanyl or to the placebo group to receive a continuous infusion of iv fluid.

Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-19
• Study First Submitted QC: 2021-06-19
• Study First Posted: 2021-06-24
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-01
• Study Start: 2021-08-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. All inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who received mechanical ventilation administered through an endotracheal tube.
2. Newborn on mechanical ventilator for at least 72 hours.

Exclusion Criteria

1. Known genetic or chromosomal disorders,
2. The need for postoperative analgesic therapy during the study period,
3. Major congenital anomaly,
4. Those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period.
5. Probable rapid extubation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	Fentanyl will be given within 24 hours from the initiation of mechanical ventilation at an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).

Primary Outcome Measures

Name	Time	Method
Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.	5 days	If fentanyl is able to decrease NPASS pain score. Total score is 13. A mean difference of 3 points will be considered clinically relevant.

Secondary Outcome Measures

Name	Time	Method
Adverse effects of fentanyl	5 days	Duration of mechanical ventilation (hours); chest wall rigidity (evaluated by clinical observation), diuresis, hypotension