Pain in ventilated babies
Ventilated preterm babies (<32 weeks’ gestation) are randomised in a 1:1:1 ratio using a secure online randomisation system hosted by the Nottingham Clinical Trials Unit, with allocation minimised by site, gestational age, sex, postnatal age, and prior morphine exposure. Participants receive a 120-hour continuous intravenous infusion of either high-dose dexmedetomidine (0.5 micrograms/kg/hour), low-dose dexmedetomidine (0.25 micrograms/kg/hour), or placebo, in addition to standard morphine, which is titrated based on 2–4 hourly pain assessments using the Neonatal Pain Assessment and Sedation Scale (N-PASS). All infusions begin at half the target rate for 24 hours and may be adjusted based on clinical assessments. The intervention is blinded, with identical packaging used for all groups. During the infusion, babies are monitored hourly for vital signs and daily for analgesic use and ventilation. Follow-up includes clinical outcomes at discharge and neurodevelopmental assessment at 2 years of age corrected for prematurity, using parent-completed questionnaires and clinical records.
1. <32 weeks’ gestational age at birth AND at least 160 hours from birth 2. Expected to require at least 48 hours of ventilation from randomisation 3. Receiving/requiring morphine infusion
1. Mother has received any opiates during pregnancy (excluding during labour) 2. Baby: 2.1. Has major congenital anomaly 2.2. Is hemodynamically unstable despite receiving two or more inotropes 2.3. Is highly likely to be transferred to another hospital within 5 days of randomisation 2.4. Has no realistic prospect of survival (as judged by the clinical team)