Pain in ventilated babies Other
Conditions
Interventions
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
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
6.6 Days to 1 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative dose of morphine given over 120 hours from starting the dexmedetomidine or placebo infusion, measured using medication administration records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured over 120 hours from the start of infusion: 1. Pain is measured using a standardised preterm pain scale at baseline and every 4 hours over 120 hours from the start of infusion 2. Total duration of morphine infusion is measured in hours using infusion records over 120 hours from the start of infusion 3. Use of additional morphine bolus is measured using medication administration records over 120 hours from the start of infusion 4. Total additional morphine is measured in mg/kg and number of boluses using medication administration records over 120 hours from the start of infusion 5. Morphine and dexmedetomidine exposure is measured using Area Under the Concentration Time Curve (AUC) derived from plasma samples collected over 120 hours from the start of infusion 6. Total dose and duration of other analgesics are measured using medication administration records over 120 hours from the start of infusion 7. Total duration of ventilation is measured in hours using respiratory support records over 120 hours from the start of infusion 8. Number of episodes of bradycardia requiring intervention is measured using clinical observation and intervention records over 120 hours from the start of infusion 9. Heart rate is measured using bedside monitoring data assessed hourly over 120 hours from the start of infusion 10. Blood pressure is measured using bedside monitoring data assessed every two hours over 120 hours from the start of infusion 11. Oxygen saturation is measured using bedside monitoring data assessed hourly over 120 hours from the start of infusion 12. FiO2 is measured using ventilator or oxygen delivery system data assessed hourly over 120 hours from the start of infusion 13. Requirement of additional vasopressor support is measured using medication administration records over 120 hours from the start of infusion Measured at discharge from neonatal care: 14. Preterm brain injury is measured using cranial ultrasound or MRI at discharg | — |
Countries
United Kingdom
Outcome results
None listed