• Pain · May 2017

    Randomized Controlled Trial Multicenter Study

    Follow-up at the corrected age of 24 months of preterm newborns receiving continuous infusion of fentanyl for pain control during mechanical ventilation.

    • Gina Ancora, Paola Lago, Elisabetta Garetti, Anna Pirelli, Daniele Merazzi, Luca Pierantoni, Fabrizio Ferrari, and Giacomo Faldella.
    • aNeonatology and Neonatal Intensive Care Unit, Dipartimento Materno-Infantile, Azienda Sanitaria Locale Romagna, Ospedale Rimini, Rimini, Italy bNeonatal Intensive Care Unit, Dipartimento di Salute della Donna e del Bambino, Azienda Ospedaliera Universitaria di Padova, Padova, Italy cNeonatal Intensive Care Unit, Azienda Ospedaliera Universitaria di Modena, Modena, Italy dNeonatal Intensive Care and Neonatology, Fondazione MBBM, Azienda Ospedaliera San Gerardo, Monza, Italy eNeonatal Intensive Care Unit and Neonatology, Azienda Ospedaliera Ospedale Sant'Anna, Como, Italy fNeonatal Intensive Care Unit and Neonatology, Ospedale Sant'Orsola-Malpighi, Bologna, Italy.
    • Pain. 2017 May 1; 158 (5): 840-845.

    AbstractThe neurodevelopmental impact of fentanyl given to preterm newborns for pain control is still unknown. The aim of this study was to assess the neurodevelopmental impact of 2 regimens of fentanyl administration by a prospective follow-up evaluation. In our previous multicenter, double-blind, randomized controlled trial, 131 mechanically ventilated newborns (gestational age ≤32 weeks) were randomized to fentanyl (continuous infusion of fentanyl + open label boluses of fentanyl) or placebo (continuous infusion of placebo + open label boluses of fentanyl). Infant development was evaluated using Griffiths Mental Developmental Scales (Griffiths, 1996) until 24 months of corrected age by trained psychologists who were not aware of the group allocation. 106/131 infants survived at discharge; 3 died after discharge, 25 were lost to follow-up (12 in the fentanyl and 13 in the placebo group). Seventy-eight patients were evaluated at 2 years of corrected age. Children in the fentanyl group, compared with those in the placebo group, obtained significantly lower Griffiths general developmental quotient (mean [SD]: 89.95 [13.64] vs 97.18 [12.72], P = 0.024) together with the scores on the eye-hand coordination (mean [SD]: 89.09 [12.13] vs 99.19 [13.19], P = 0.002) and performance skills (mean [SD]: 79.71 [15.80] vs 90.09 [15.28], P = 0.009) scales. After adjustment for clinical confounders (gestational age, CRIB score, and sex) only eye-hand co-ordination was associated with fentanyl infusion. This study demonstrates that continuous infusion of fentanyl in very preterm infants, given at 1 mcg·kg·h during mechanical ventilation, is associated with a significant decrease in eye and hand co-ordination skills. Longer follow-up is needed to evaluate the impact on future motor, cognitive, and behavioral functions.

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