Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial

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 intraventricu...

Full description

Saved in:
Bibliographic Details
Published in:The Lancet (British edition) 2004-05, Vol.363 (9422), p.1673-1682
Main Authors: Anand, KJS, Hall, R Whit, Desai, Nirmala, Shephard, Barbara, Bergqvist, Lena L, Young, Thomas E, Boyle, Elaine M, Carbajal, Ricardo, Bhutani, Vinod K, Moore, Mary Beth, Kronsberg, Shari S, Barton, Bruce A
Format: Article
Language:English
Subjects:
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - adverse effects
Babies
Biological and medical sciences
Clinical trials
Comparative analysis
Double-Blind Method
Female
General aspects
Humans
Infant Mortality
Infant, Newborn
Infant, Premature
Infusions, Intravenous
Intensive Care, Neonatal
Intracranial Hemorrhages - prevention & control
Leukomalacia, Periventricular - prevention & control
Male
Medical sciences
Medicin och hälsovetenskap
Morphine - administration & dosage
Morphine - adverse effects
Mortality
Narcotics
Neonates
Pain
Respiration, Artificial
Treatment Outcome
Ventilation
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. 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
ISSN:0140-6736
1474-547X
1474-547X
DOI:10.1016/S0140-6736(04)16251-X