Efficacy and Safety of Fentanyl for Pain Control in Newborns on Mechanical Ventilation
Overview
- Phase
- Phase 4
- Intervention
- Fentanyl
- Conditions
- Mechanical Ventilation Complication
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Enrollment
- 40
- Primary Endpoint
- Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.
- Last Updated
- 4 years ago
Overview
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 .
Investigators
Kundan Kumar Yadav
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Eligibility Criteria
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.
Arms & Interventions
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 ).
Intervention: Fentanyl
Outcomes
Primary Outcomes
Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.
Time Frame: 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 Outcomes
- Adverse effects of fentanyl(5 days)