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

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

Detailed Description
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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 .

Official Title
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Efficacy and Safety of Fentanyl for Pain Control in Newborns on Mechanical Ventilation

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who received mechanical ventilation administered through an endotracheal tube. Newborn on mechanical ventilator for at least 72 hours. Exclusion Criteria: Known genetic or chromosomal disorders, The need for postoperative analgesic therapy during the study period, Major congenital anomaly, Those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period. Probable rapid extubation.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl<br>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 ). | Drug: Fentanyl<br>* 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 .<br>|
| No Intervention: Placebo<br>Will receive continuous infusion of IV fluid up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ). | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of fentanyl | Duration of mechanical ventilation (hours); chest wall rigidity (evaluated by clinical observation), diuresis, hypotension | 5 days |