Background

    Fentanyl is commonly used for analgesia in newborn infants. The drug has a rapid clearance in adults. But hepatic metabolism is immature at birth, thus the half- life is prolonged in neonates. So, intermittent doses of fentanyl may be as good as continuous infusion in maintaining serum concentrations and hence the analgesic efficacy in neonates. 

Aim

    To compare continuous infusion and intermittent doses of fentanyl for analgesia in neonates using serum concentrations, pain scores and side-effects

Methods

    In the present study, newborn babies who are likely to need mechanical ventilation and hence analgesia and sedation for preferably 48 hours (minimum of 24 hours) will be recruited into the study after informed written consent. The babies will be stratified into 2 categories of <32 weeks or ≥32 weeks gestational age. In both groups, babies will be administered a loading dose of fentanyl (1 microgram/kg/dose) at the time of intubation, or at the time of starting ventilator care if the baby has already been intubated in the labour room or casualty. 

   Babies will be randomized into two groups: continuous infusion of fentanyl (Group 1) or intermittent doses once in every 4 hours (Group 2). The babies in the continuous group and intermittent group will be compared based on: 1) serum fentanyl concentrations 2) clinical efficacy 3) adverse effects. 

   Serum concentrations of fentanyl will be estimated as follows: 

Group 1 - Continuous infusion - samples (0.5 ml) will be collected

a. Prior to starting continuous infusion(0 hour) and at 2,8 and 24 hours from start of infusion

b. At 36 and 48 hours - 2 samples on Day 2