Dexmedetomidine versus Fentanyl for sedation and analgesia in ventilated neonates an open labelled pilot randomized controlled study

Study Title-Dexmedetomidine versus fentanyl for sedation and analgesia in ventilated neonates an open labelled randomized controlled trial.

This is a pilot randomized trail aims to compare dexmedetomidine and fentanyl for providing sedation and analgesia in mechanically ventilated neonates admitted to a level III neonatal intensive unit at IMS and SUM hospital Bhubaneswar. This study is planned for duration of 18 months from march 2026 to august 2027. This study will recruit 100 neonates with 50 neonates in each arm.

 The primary objective is to compare the efficacy of dexmedetomidine versus fentanyl in achieving adequate sedation and analgesia in ventilated neonates assessed using comfort neo score. Adequate sedation is defined as comfortneo score less than 14. Secondary objectives are comparison of requirement for additional rescue sedatives, duration of mechanical ventilation duration of sedation. Incidence and severity of withdrawal symptoms assessed using the modified Finnegan neonatal abstinence score. Incidence of adverse events like bradycardia, hypotension and arrythmia will be recorded and necessary action will be taken.

 This is an open labelled randomized controlled trial. Eligible neonates will be randomized using computer generated randomization with block size of 4, 6 and 8. Allocation concealment will be ensured through serially arranged opaque sealed envelopes. Inclusion criteria are neonates with gestational age between 28 to 44 weeks requiring mechanical ventilation with ventilator asynchrony or comfortneo score more than 14. Neonates with congenital malformation or chromosomal anomalies, prior exposure to opioids within 12hrs, grade III IVH or more, moderate to severe encephalopathy and post surgical cases will be excluded. Parents retain the right to withdraw their neonates from study at any time.

 After obtaining informed consent, baseline parameter will be documented and randomization will be performed. In the dexmedetomidine group infusion will begin at 0.2 mcg per kg per hour and will be increased every 30 mins up to maximum 0.8 mcg per kg per hour until target sedation score is achieved that is comfortneo score less than 14. If adequate sedation is not achieved at maximum dose fentanyl will be added as rescue therapy starting at 1 mcg per kg per hours and titrated upto maximum a maximum 4 mcg per kg hour. Similarly in fentanyl group infusion will be started at 1 mcg per kg per hour and its maximum infusion rate will be 4 mcg per kg per hour. Similarly, dexmedetomidine infusion will be started if fentanyl alone failed to achieve targeted sedation score with 0.2 mcg per kg per hour till its maximum dose 0.8 mcg per hour.

 Weaning of sedation depends on duration and number of sedatives used. For sedation less than 3days with single agent, abrupt discontinuation is permitted. Sedation required more than 3days, gradual weaning will be done every six hourly. Withdrawal assessment will be performed using Modified Finnegan score for 72 hours after discontinuation of sedatives.

The primary outcome will be the proportion of neonates remaining with in target sedation range that is comfortneo score less than 14. Secondary outcomes include need for additional sedation, duration of sedation, duration of mechanical ventilation, withdrawal symptoms and incidence of adverse events. This study aims to generate evidence regarding the efficacy and safety of dexmedetomidine compared to fentanyl for sedation in ventilated neonates.