A study of intranasal remifentanil for intubation and surfactant administration in newborns

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: Prior to the intubation surfactant extubation (INSURE) procedure, babies will receive standard care plus intranasal remifentanil 2 micrograms/kg. CONDITION: Pain management for premature infants undergoing intubation. PRIMARY OUTCOME: The proportion of infants with good or excellent intubating conditions. ; ; Base‐line cardiorespiratory and sleep‐wake data will be recorded in order to calculate the immediate post‐procedural Premature Infant Pain Profile (PIPP) score. Real‐time physiological data will be downloaded from monitors for later analysis. These include: blood pressure obtained using an arterial transducer or a non‐invasive blood pressure module; heart rate obtained from an electrocardiogram lead attached to cardiogram/respiratory monitor; and oxygen saturation obtained from an oxygen saturation monitor. SECONDARY OUTCOME: Adverse events including episodes of bradycardia and number of neonates requiring intervention (volume expanders or inotropes) for hypotension Neonatal outcome at discharge from NICU (satisfactory weight gain, equivalent to term corrected, breathing on own without respiratory support, can suck and feed without the need of assistance eg. gastric tube feeding, can maintain body temperature). Number of intubation attempts and total duration (limit of 3 attempts OR 20 seconds each attempt OR intubation associated with desaturations and bradycardia). Pain assessed using the Premature Infant Pain Profile (PIPP) score Ventilatory changes INCLUSION CRITERIA: Born at John Hunter Childrens Hospital and transferred to Neonatal Intensive Care Unit. Require the INSURE procedure as part of their medical care. Are 28–44 weeks post‐conceptional age at the time of the procedure.
Epistemonikos ID: 5ccb9efbf9d119a897651210b1e90e0fc80c59f2
First added on: Aug 22, 2024