Randomized Controlled Trial Comparing Different Single Doses of Intravenous Paracetamol for Placement of Peripherally Inserted Central Catheters in Preterm Infants

Abstract

Background: The availability of a safe and effective pharmacological therapy to reduce procedural pain in preterm infants is limited. The effective analgesic single dose of intravenous paracetamol in preterm infants is unknown. Comparative studies on efficacy of different paracetamol doses in preterm infants are lacking. Objectives: To determine the analgesic effects of different single intravenous paracetamol doses on pain from peripherally inserted central catheter (PICC) placement in preterm infants. Methods: In a blinded randomized controlled trial, the analgesic effects of 10-, 15-, and 20-mg/kg single-dose intravenous paracetamol before PICC placement were compared in neonates with a gestational age <32 weeks. Secondly, a separate age-matched nonrandomized control group receiving oral sucrose was included. Pain was assessed with the Premature Infant Pain Profile (PIPP) and the COMFORTneo score. Peak plasma concentrations of paracetamol were determined. Results: A total of 60 patients were included in the paracetamol dose groups (median gestational age = 27.8, IQR: 25.7-29.2 weeks). PIPP scores were comparable: median = 8 (IQR: 6-10.5), 7 (IQR: 6-9), and 8 (IQR: 6-10) for the 10-, 15-, and 20-mg/kg paracetamol groups, respectively (p = 0.94). COMFORTneo scores were not statistically different between the different paracetamol dose groups (p = 0.35). All randomized subjects, except for 3 who received 10 mg/kg of paracetamol, had peak paracetamol concentrations >9 mg/L. PIPP (p = 0.78) and COMFORTneo (p = 0.08) scores were also comparable between paracetamol- and sucrose-treated patients. Conclusions: We found no analgesic benefit from intravenous paracetamol studied in different single doses over sucrose for PICC placement in preterm infants. Paracetamol is not a suitable analgesic for this procedure in preterm infants.

The positioning of the catheter tip with an intracavitary electrocardiogram in epicutaneo–caval catheter placement via lower limbs in newborns: A retrospective study

“…The principle is to convert the intra-atrial ECG to the body surface ECG through an intracardiac connection converter and directly observe changes in the cardiac P-wave electrophysiology under ECG monitoring. [21][22][23][24] However, the study of the tip location with the intracavitary ECG method for lower extremity ECC placement is still in its infancy. The focus of this study was to explore the feasibility of this technology for use in lower extremity central venous catheterisation.…”

A Critical Review on the Relevance of Paracetamol for Procedural Pain Management in Neonates

“…When compared to non-pharmacological interventions (sucrose and dextrose), paracetamol-related analgesia was less effective to these nonpharmacological interventions. Similarly, Roofthooft et al also concluded that intravenous paracetamol (10, 15, or 20 mg/kg) was not effective (PIPP score and Comfort-Neo) as an analgesic during PICC placement in 60 preterm (<32 weeks) neonates, irrespective of the dose administered (67). This is in line with similar findings on the absence of an analgesic effect of even high doses of paracetamol (40 mg/kg oral) on pain, fear, or distress as reported in a cohort of children with oncological diseases when they had to undergo a needle insertion into their subcutaneous implanted venous access (68).…”

Analgesia and Sedation in Newborns with Long-Term Mechanical Ventilation

“…Ацетаминофен является жаропонижающим средством, а также слабым анальгетиком, использование которого возможно у новорожденных детей. В настоящее время отсутствуют убедительные доказательства эффективности препарата в монотерапии острой боли [40,41], однако есть данные, что в комбинации с наркотическими анальгетиками для лечения послеоперационной боли ацетаминофен обладает опиоидсберегающим эффектом [42,43]. Исследования эффективности ацетаминофена в лечении боли и стресса у детей на ИВЛ отсутствуют.…”