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Database - Alliance francophone pour l'accouchement respecté (AFAR)

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Created on : 28 May 2004
Modified on : 02 Dec 2007

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Bibliographical entry (without author) :

Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial. The Lancet 2004;363(9422):1673-82.

Author(s) :

Anand KJS, Hall, RW, Desai, N, et al.

Year of publication :


URL(s) :

Résumé (français)  :

Abstract (English)  :

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 µg/kg), morphine infusions (23-26 weeks of gestation 10 µg kg-1 h-1;
27-29 weeks 20 µg kg-1 h-1; 30-32 weeks 30 µg 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.

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Keywords :

➡ premature baby ; newborn care ; pain medication ; pain

Author of this record :

Cécile Loup — 28 May 2004

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