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Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Anestheslogy, Neurobiology, and Pharmacology, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Department of Pediatrics, University of Kentucky Medical Center, Lexington, KY.
Department of Pediatrics, Tufts University School of Medicine, Boston, MA.
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2004 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 363, no 9422, p. 1673-82Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Opioid analgesia is commonly used during neonatal intensive care. We undertook the Neurologic Outcomes and Pre-emptive Analgesia in Neonates (NEOPAIN) trial to investigate whether pre-emptive morphine analgesia decreases the rate of a composite primary outcome of neonatal death, severe intraventricular haemorrhage (IVH), and periventricular leucomalacia (PVL) in preterm neonates.

METHODS: Ventilated preterm neonates (n=898) from 16 centres were randomly assigned masked placebo (n=449) or morphine (n=449) infusions. After a loading dose (100 microg/kg), morphine infusions (23-26 weeks of gestation 10 microg kg(-1) h(-1); 27-29 weeks 20 microg kg(-1) h(-1); 30-32 weeks 30 microg kg(-1) h(-1)) were continued as long as clinically justified (maximum 14 days). Open-label morphine could be given on clinical judgment (placebo group 242/443 [54.6%], morphine group 202/446 [45.3%]). Analyses were by intention to treat.

FINDINGS: Baseline variables were similar in the randomised groups. The placebo and morphine groups had similar rates of the composite outcome (105/408 [26%] vs 115/419 [27%]), neonatal death (47/449 [11%] vs 58/449 [13%]), severe IVH (46/429 [11%] vs 55/411 [13%]), and PVL (34/367 [9%] vs 27/367 [7%]). For neonates who were not given open-label morphine, rates of the composite outcome (53/225 [24%] vs 27/179 [15%], p=0.0338) and severe IVH (19/219 [9%] vs 6/189 [3%], p=0.0209) were higher in the morphine group than the placebo group. Placebo-group neonates receiving open-label morphine had worse rates of the composite outcome than those not receiving open-label morphine (78/228 [34%] vs 27/179 [15%], p<0.0001). Morphine-group neonates receiving open-label morphine were more likely to develop severe IVH (36/190 [19%] vs 19/219 [9%], p=0.0024).

INTERPRETATION: Pre-emptive morphine infusions did not reduce the frequency of severe IVH, PVL, or death in ventilated preterm neonates, but intermittent boluses of open-label morphine were associated with an increased rate of the composite outcome. The morphine doses used in this study decrease clinical signs of pain but can cause significant adverse effects in ventilated preterm neonates.

Place, publisher, year, edition, pages
2004. Vol. 363, no 9422, p. 1673-82
National Category
Anesthesiology and Intensive Care
Identifiers
URN: urn:nbn:se:oru:diva-34581DOI: 10.1016/S0140-6736(04)16251-XISI: 000221546300007PubMedID: 15158628Scopus ID: 2-s2.0-2442691352OAI: oai:DiVA.org:oru-34581DiVA, id: diva2:710027
Funder
NIH (National Institute of Health)Available from: 2014-04-04 Created: 2014-04-04 Last updated: 2017-12-05Bibliographically approved

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