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Morphine Infusion Results in Significant Adverse Effects in Ventilated Preterm Neonates
Lancet
05/21/2004
By Joene Hendry
Morphine infusion decreases clinical signs of pain but is associated with significant adverse effects in ventilated preterm neonates, according to the findings of the Neurologic Outcomes and Pre-emptive Analgesia in Neonates (NEOPAIN) study.
"The results suggest that continuous morphine infusion does not reduce early neurological injury in ventilated preterm neonates, contrary to the findings of previous pilot studies," writes Professor K. J. S. Anand, DPhil, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, United States, and colleagues.
The researchers assessed the composite outcome of neonatal death, severe intraventricular haemorrhage (IVH), and periventricular leukomalacia (PVL) in 898 ventilated preterm neonates equally randomised to morphine infusions or placebo for a maximum of 14 days. Patients in the morphine group received a 100 microgram/kg loading dose then infusions at 10, 20, or 30 µg/kg-1/h-1 according to respective gestational age of 23-26 weeks, 27-29 weeks, or 30-32 weeks.
Baseline variables were similar between the randomised treatment groups. According to clinical judgment, 45.3% of the patients in the morphine group and 54.6% of those in placebo also received open-label morphine.
While infants in the morphine group showed significantly lower scores 24 hours after infusion on the premature infant pain profile than the placebo group, 8.00 vs 8.77, respectively, the investigators report "no significant differences in the frequency of the composite outcome or its components (death, severe IVH, or PVL) between the two randomised groups." Overall, composite outcome rates were 27% in the morphine group and 26% in the placebo group, while rates of severe IVH were 13% and 11%, of PVL were 7% and 9%, and of death were 13% and 11% in the morphine and placebo groups, respectively.
Neonates who did not receive additional open-label morphine had higher rates of the composite outcome, 24%, and higher rates of severe IVH, 9%, compared with 15% and 3%, respectively, in the placebo group. Open-label morphine also resulted in worse composite outcome rates among the infants in the placebo group, 34%, when compared with those not given open-label morphine, 15%.
"Perhaps preterm neonates would benefit from lower doses than those used in this study, or hourly variations in the infusion rate (dictated by expected procedures or disease-related pain), or sedation rather than analgesia," the authors note. They conclude, "The NEOPAIN trial suggests that intravenous morphine analgesia, like any other potent therapy, should be used judiciously and cautiously," in this patient population.
Lancet 2004;363:1673-82
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