Routine use of fentanyl infusions for pain and stress reduction in infants with respiratory distress syndrome,☆☆,

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Abstract

OBJECTIVE: To determine whether fentanyl infusions given to premature infants with respiratory distress syndrome reduce stress and improve long- and short-term outcome. METHODS: Twenty premature infants undergoing mechanical ventilation for respiratory distress syndrome were randomly assigned, in a double-blind fashion, to receive fentanyl by continuous infusion or a volume-matched placebo infusion. A behavioral state score was used to assess the infants' behavior. Cortisol and 11-deoxycortisol levels were measured as physiologic markers of stress. Urinary 3-methyl histidine/creatinine molar ratio was determined and the fractional excretion of urea was measured to assess catabolic state. Ventilatory indexes were recorded for each infant. RESULTS: Infants receiving fentanyl showed significantly lower behavioral state scores (p <0.04) and lower heart rates (p <0.001) than those receiving placebo. 11-Deoxycortisol levels were lower in the fentanyl group on days 3, 4, and 5 of the study (p <0.003). 3-Methyl histidine/creatinine ratios and fractional excretion of urea were not significantly different between the two groups. On the third day of the study, infants receiving fentanyl required a higher ventilator rate (p <0.01), higher peak inspiratory pressures (p <0.001), and higher positive end-expiratory pressure (p <0.0001) than those receiving placebo. There was no difference in long-term outcome with respect to the incidence of bronchopulmonary dysplasia, intraventricular hemorrhage, or sepsis or with respect to the duration of ventilator use. CONCLUSIONS: Although there was a reduction in stress markers in the infants receiving fentanyl, we were unable to demonstrate an improvement in catabolic state or long-term outcome. In addition, the infants receiving fentanyl required higher ventilatory support in the early phase of respiratory distress syndrome than did those receiving placebo. (J PEDIATR 1996;129:140-5)

Section snippets

METHODS

This study was approved by the investigational review board at the Medical Center of Delaware. After informed parental consent was obtained, 20 premature neonates receiving mechanical ventilation for RDS were enrolled in this investigation. To be eligible for this study, infants had to have clinical and radiographic evidence of RDS, have a birth weight greater than 1 kg and a gestational age of 26 to 36 weeks, be receiving mechanical ventilation, and have an indwelling arterial catheter. All

RESULTS

Twenty infants were enrolled into this study. Nine infants were randomly assigned to receive placebo and 11 infants to receive fentanyl. Patient characteristics are listed in Table I. Of the 20 infants, 19 received exogenous surfactant (Exosurf) as treatment for RDS. There were no differences in race, sex, Apgar scores, or method of delivery between the two groups.

Data are shown in Table II (all data are mean ± SD). There were no differences at 8 hours into the study with respect to any of the

DISCUSSION

The results of this study indicate that although fentanyl can alter physiologic indicators of pain and stress when given routinely to infants with RDS, there was no improvement in catabolic state or long-term outcome. In addition, the data also show that infants receiving fentanyl required increased ventilatory support in comparison with the infants receiving placebo.

Although fentanyl is currently a popular medication in neonatal practice, there are few reports available that critically examine

Acknowledgements

We thank the neonatal intensive care nurses at the Medical Center of Delaware for their help during this study. Their continued support of research and their devotion to the care of our patients is greatly appreciated.

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From the Divisions of Neonatology, Anesthesiology, and Pediatric Critical Care, Jefferson Medical College and Univerity of Pennsylvania, Philadelphia; the Medical Center of Delaware, Newark; and the Milton S. Hershey Medical Center, Hershey, Pennsylvania

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Reprint requests: John L. Stefano, MD, Division of Neonatology, Christiana Hospital, PO Box 6001, Newark, DE 19718.

0022-3476/96/$5.00 + 0 9/22/73091

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