The paracetamol concentration‐effect relation in neonates

Allegaert, Karel; Naulaers, Gunnar; Vanhaesebrouck, Sophie; Anderson, Brian J.

doi:10.1111/pan.12076

Cited by 74 publications

(67 citation statements)

References 23 publications

(57 reference statements)

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“…The fact that it has recently been described that the effect compartment concentration of 10 mg/L of acetaminophen, achieved following a loading dose administration (20 mg/kg, intravenous) in neonates, is effective for moderate pain relief further provides evidence that the absence of effects likely at least in part relates to insufficient dosing [180].…”

Section: Acetaminophen (Paracetamol)mentioning

confidence: 96%

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Sedation in the Neonatal Intensive Care Unit: International Practice

Allegaert

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2014

Pediatric Sedation Outside of the Operating Room

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Inadequate pain management in neonatal life impairs neurodevelopmental outcome because it alters pain thresholds, pain-or stress-related behavior, and physiological responses later in life. However, there are recently also emerging animal experimental and human epidemiological data on the impact of analgo-sedatives on neuro-apoptosis and impaired neurodevelopmental outcome. As a consequence, the management of neonatal pain is in search of a new balance, and these conflicting observations are the main drivers to tailor our pain management in neonates. Adequate pain management is based on prevention, assessment, and treatment with subsequent reassessment. Issues related to prevention and assessment tools are covered. Non-pharmacological (e.g., complementary interventions like facilitated tucking, nonnutritive sucking) and pharmacological (e.g., acetaminophen, opioids, ketamine, propofol) treatment modalities were reviewed and reflect the increased knowledge on neonatal pain management. Each topic ends with some take-home messages that in part also reflect our opinion on the current status of this topic.

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Section: Acetaminophen (Paracetamol)mentioning

confidence: 96%

“…• Data on acetaminophen pharmacokinetics/dynamics have been published and suggest that the same effect compartment concentration (10 mg/L) of acetaminophen should be aimed for in neonates [174,175,180].…”

Section: Take-home Messagesmentioning

confidence: 98%

Sedation in the Neonatal Intensive Care Unit: International Practice

Allegaert

Anker

2014

Pediatric Sedation Outside of the Operating Room

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“…While there are data from pharmacokinetics studies [12,13], the pharmacodynamics of paracetamol in neonates are poorly described. Allegaert et al [14] showed a reduction of pain after 20 mg/kg of paracetamol in preterm and term infants suffering from delivery trauma. Pharmacokinetics studies on intravenous paracetamol in preterm infants also suggest that a loading dose of 20 mg/kg intravenous paracetamol for neonates with postconceptional ages of 28-32 weeks and body weights above 1.5 kg is sufficient for pain relief [15].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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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.

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“…On the other hand, paracetamol is an analgesic drug with proven efficacy also in very young patients [53,54 && ], a causal relation between its use and the development of asthma is not proven [55 && ]. NSAIDs and dexamethasone are administered for the prevention of post-tonsillectomy pain.…”

Section: Painmentioning

confidence: 99%