Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates

Summary

This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are: Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.

Timeline

Start

2023-01-10

Primary completion

2024-01-10

Completion

2024-01-10

Publications

• Results Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, Rogers M, Mackay M, Hubber-Richard P, Johannesen D. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. Pain. 2009 May;143(1-2):138-46. doi: 10.1016/j.pain.2009.02.014.
• Results Cuzzolin L, Antonucci R, Fanos V. Paracetamol (acetaminophen) efficacy and safety in the newborn. Curr Drug Metab. 2013 Feb;14(2):178-85.
• Results Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007.
• Results Walls L, Baker CF, Sarkar S. Acetaminophen-induced hepatic failure with encephalopathy in a newborn. J Perinatol. 2007 Feb;27(2):133-5. doi: 10.1038/sj.jp.7211641.
• Results Hansen TG, O'Brien K, Morton NS, Rasmussen SN. Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants. Acta Anaesthesiol Scand. 1999 Sep;43(8):855-9. doi: 10.1034/j.1399-6576.1999.430813.x.
• Results Anderson BJ, van Lingen RA, Hansen TG, Lin YC, Holford NH. Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis. Anesthesiology. 2002 Jun;96(6):1336-45. doi: 10.1097/00000542-200206000-00012.
• Results Capici F, Ingelmo PM, Davidson A, Sacchi CA, Milan B, Sperti LR, Lorini L, Fumagalli R. Randomized controlled trial of duration of analgesia following intravenous or rectal acetaminophen after adenotonsillectomy in children. Br J Anaesth. 2008 Feb;100(2):251-5. doi: 10.1093/bja/aem377.

Drugs

Indications

No indication recorded.