Abstract
Introduction
Therapeutic hypothermia is the standard care for asphyxiated newborns. Discomfort and pain during treatment are common and may affect therapeutic efficacy of hypothermia. Opioid analgosedation is commonly used in the clinical setting, but its effects in the cooled newborns is poorly investigated.
Objective
The aim of this study was to assess the safety of fentanyl analgosedation during therapeutic hypothermia, by evaluating severe adverse effects and possible correlation with the neurodevelopmental outcome.
Methods
We analyzed asphyxiated newborns treated with hypothermia receiving fentanyl intravenous infusion (years 2013–2018). Severe neurodevelopmental outcome was defined as cerebral palsy or Griffith’s developmental quotient <70 or major sensorineural deficit. Severe brain lesions were defined as cortical or/and basal ganglia extensive involvement.
Results
Fentanyl cumulative dose was variable (61.7 ± 18.5 µg/kg; range 34.3–120.3 µg/kg) among 45 enrolled patients. Respiratory depression was recorded in 13.3% cases of 30 spontaneously breathing patients. Severe brain lesions and severe neurodevelopmental disability were found in 24.4 and 11.1% of all included cases, respectively. Higher cumulative fentanyl dose was not associated with poor outcome.
Conclusions
Fentanyl treatment during therapeutic hypothermia does not negatively affect the neurodevelopmental outcome, thus on the contrary, it may contribute to ameliorate neuroprotection in the asphyxiated cooled newborns.
Ethical approval
This study complies with the guidelines for human studies and the research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. The study protocol was approved by the institute’s committee on human research. Parents of enrolled patients gave their written informed consent.
Acknowledgments
We acknowledge all medical and nurse staff who contributed to the study. No funding source.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
Original data are available in electronic format, if requested.