The safety and value of acetaminophen (paracetamol) in addition to continuous morphine infusion has never been studied in newborns and young infants. We investigated the addition of acetaminophen to evaluate whether it decreased morphine consumption in this age group after major thoracic (non-cardiac) or abdominal surgery.Methods
A randomized controlled trial was performed in 71 patients given either acetaminophen 90–100 mg kg−1 day−1or placebo rectally, in addition to a morphine loading dose of 100 µg kg−1 and 5–10 µg kg−1 h−1 continuous infusion. Analgesic efficacy was assessed using Visual Analogue Scale (VAS) and COMFORT scores. Extra morphine was administered if VAS was ≥4.Results
We analysed data of 54 patients, of whom 29 received acetaminophen and 25 received placebo. Median (25–75th percentile) age was 0 (0–2) months. Additional morphine bolus requirements and increases in continuous morphine infusion were similar in both groups (P=0.366 and P=0.06, respectively). There was no significant difference in total morphine consumption, respectively, 7.91 (6.59–14.02) and 7.19 (5.45–12.06) μg kg−1 h−1 for the acetaminophen and placebo group (P=0.60). COMFORT [median (25–75th percentile) acetaminophen 10 (9–12) and placebo 11 (9–13)] and VAS [median (25–75th percentile) acetaminophen 0.0 (0.0–0.2) and placebo 0.0 (0.0–0.3)] scores did not differ between acetaminophen and placebo group (P=0.06 and P=0.73, respectively).Conclusions
Acetaminophen, as an adjuvant to continuous morphine infusion, does not have an additional analgesic effect and should not be considered as standard of care in young infants, 0–2 months of age, after major thoracic (non-cardiac) or abdominal surgery.