Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation.

Abstract

OBJECTIVE:

To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation.

STUDY DESIGN:

In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well.

RESULTS:

Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were >6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P < .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively).

CONCLUSION:

In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone.

• Authors: Gina Ancora, Paola Lago, Elisabetta Garetti, Anna Pirelli, Daniele Merazzi, Maura Mastrocola, Luca Pierantoni, Giacomo Faldella
• Journal: The Journal of pediatrics (J Pediatr) Vol. 163 Issue 3 Pg. 645-51.e1 (Sep 2013) ISSN: 1097-6833 [Electronic] United States
• PMID: 23582138 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Mosby, Inc. All rights reserved.

Chemical References

• Analgesics, Opioid
• Fentanyl

Topics

• Analgesics, Opioid (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Fentanyl (administration & dosage, adverse effects, therapeutic use)
• Follow-Up Studies
• Humans
• Infant, Newborn
• Infant, Premature
• Infant, Premature, Diseases (therapy)
• Infusions, Intravenous
• Injections, Intravenous
• Logistic Models
• Male
• Pain (drug therapy, etiology)
• Pain Measurement
• Respiration, Artificial (adverse effects)
• Respiratory Insufficiency (therapy)
• Treatment Outcome