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Routine Morphine Infusion in Preterm Newborns Who Received Ventilatory Support
A Randomized Controlled Trial
Sinno H. P. Simons, MSc;
Monique van Dijk, PhD;
Richard A. van Lingen, MD, PhD;
Daniella Roofthooft, MD;
Hugo J. Duivenvoorden, PhD;
Niesje Jongeneel, RN;
Carin Bunkers, RN;
Enna Smink, RN;
K. J. S. Anand, MBBS, DPhil;
John N. van den Anker, MD, PhD;
Dick Tibboel, MD, PhD
JAMA. 2003;290:2419-2427.
Context Newborns admitted to neonatal intensive care units (NICUs) undergo a variety of painful procedures and stressful events. Because the effect of continuous morphine infusion in preterm neonates has not been investigated systematically, there is confusion regarding whether morphine should be used routinely in this setting.
Objective To evaluate the effects of continuous intravenous morphine infusion on pain responses, incidence of intraventricular hemorrhage (IVH), and poor neurologic outcome (severe IVH, periventricular leukomalacia, or death).
Design, Setting, and Patients A randomized, double-blind, placebo-controlled trial conducted between December 2000 and October 2002 in 2 level III NICUs in the Netherlands of 150 newborns who had received ventilatory support (inclusion criteria: postnatal age younger than 3 days and ventilation for less than 8 hours; exclusion criteria: severe asphyxia, severe IVH, major congenital malformations, and administration of neuromuscular blockers).
Interventions Intravenous morphine (100 µg/kg and 10 µg/kg per hour) or placebo infusion was given for 7 days (or less because of clinical necessity in several cases).
Main Outcome Measures The analgesic effect of morphine, as assessed using validated scales; the effect of morphine on the incidence of IVH; and poor neurologic outcome.
Results The analgesic effect did not differ between the morphine and placebo groups, judging from the following median (interquartile range) pain scores: Premature Infant Pain Profile, 10.1 (8.2-11.6) vs 10.0 (8.2-12.0) (P = .94); Neonatal Infant Pain Scale, 4.8 (3.7-6.0) vs 4.8 (3.2-6.0) (P = .58); and visual analog scale, 2.8 (2.0-3.9) vs 2.6 (1.8-4.3) (P = .14), respectively. Routine morphine infusion decreased the incidence of IVH (23% vs 40%, P = .04) but did not influence poor neurologic outcome (10% vs 16%, P = .66). In addition, analyses were adjusted for the use of additional open-label morphine (27% of morphine group vs 40% of placebo group, P = .10).
Conclusions Lack of a measurable analgesic effect and absence of a beneficial effect on poor neurologic outcome do not support the routine use of morphine infusions as a standard of care in preterm newborns who have received ventilatory support. Follow-up is needed to evaluate the long-term effects of morphine infusions on the neurobehavioral outcomes of prematurity.
Author Affiliations: Departments of Pediatric Surgery (Drs van Dijk and Tibboel and Mr Simons) and Pediatrics (Dr van den Anker), and Division of Neonatology (Dr Roofthooft, Mr Simons, and Ms Jongeneel), Erasmus MC-Sophia, and Department of Medical Psychology, Erasmus-MC (Dr Duivenvoorden), Rotterdam, the Netherlands; Department of Pediatrics, Division of Neonatology, Isala Clinics, Zwolle, the Netherlands (Dr van Lingen and Mss Bunkers and Smink); Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock (Dr Anand); and Division of Pediatric Clinical Pharmacology, Departments of Pediatrics and Pharmacology, George Washington University, Washington, DC (Dr van den Anker).
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