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

ABSTRACT: Effective and safe pain relief in neonates matters. This is not only because of ethical constraints or human empathy, but even more because pain treatment is an important and crucial part of contemporary medical, paramedical, and nursing care to improve the outcome in neonatal intensive care graduates. Paracetamol (acetaminophen) is likely one of the pharmacological tools to attain this, with data on prescription practices suggesting that paracetamol is somehow the "rising star" in neonatal pain management. Besides very rare topical clinical scenarios like peripartal asphyxia and subsequent whole body hypothermia or the use of cardiorespiratory support devices, data on paracetamol pharmacokinetics and metabolism were reported throughout neonatal age or weight ranges, and we have summarized these data. In this review, we subsequently aimed to provide the reader with the currently available observations on the use of paracetamol as analgesic for different pain syndromes (major surgery, minor surgery or trauma, and procedural pain), with focus on the limitations of paracetamol when prescribed for neonatal procedural pain management. We hereby intentionally will not discuss other indications (patent ductus arteriosus and fever) for paracetamol administration in neonates. Based on the available evidence, paracetamol has opioid-sparing effects for major pain syndromes, is effective to treat minor to moderate pain syndromes, but fails for effective procedural pain management in neonates. This efficacy failure for procedural pain management should stimulate us to continue to search for more effective interventions, including non-pharmacological interventions and preventive strategies. Furthermore, there are also upcoming association type of epidemiological studies on the relation between exposure to analgesics-including paracetamol-and the negative short- or long-term outcome characteristics (neuro-behavioral, atopy, and fertility). Consequently and in addition to the search for effective alternatives to prevent or treat pain, studies on long-term outcome following paracetamol exposure are needed to inform all stakeholders on the full effect-side effect balance of the different strategies to treat pain.

SUBMITTER: Allegaert K

PROVIDER: S-EPMC7093493 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Allegaert Karel K

Frontiers in pediatrics 20200318

Effective and safe pain relief in neonates matters. This is not only because of ethical constraints or human empathy, but even more because pain treatment is an important and crucial part of contemporary medical, paramedical, and nursing care to improve the outcome in neonatal intensive care graduates. Paracetamol (acetaminophen) is likely one of the pharmacological tools to attain this, with data on prescription practices suggesting that paracetamol is somehow the "rising star" in neonatal pain ...[more]

PMID: 32257982

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Project description:BackgroundWhile hospitalized in the NICU, preterm neonates undergo many painful procedures. This may be the same for full-term neonates when longer hospitalization is required. Untreated and repeated pain has short-term as well as long-term consequences for these neonates. Pharmacological pain management methods have many limitations in their applications for both preterm and full-term neonates. A combination of different non-pharmacological methods is recommended for pain management. The effect of olfactive stimulation as a non-pharmacological pain management method was investigated by a few studies in the past years with premature and term neonates, but no systematic review has been conducted. The objective of this systematic review is to evaluate the effect of olfactive stimulation intervention on the pain response of preterm and full-term neonates during painful procedures.MethodsAn electronic search will be conducted in various databases such as PubMed (1946 to date), MEDLINE (1946 to date), CINAHL (1981 to date), Embase (1947 to date), PsycINFO (1806 to date), Web of Science (1945 to date), CENTRAL and Scopus (1960 to date), and Proquest, without restriction for the year of publication. Only studies published in English or French will be included. The search will be conducted using the following three concepts: pain, odors, and neonates. Selection of articles, data extraction, and assessment of risk of bias will be conducted by two independent researchers. A third researcher will intervene in case of disagreement. According to the availability of studies and data homogeneity, the results will be combined to perform a meta-analysis, or they will be described by a narrative synthesis.DiscussionThis systematic review will provide light on the current state of knowledge on the effectiveness of olfactive stimulation interventions for managing pain in preterm and full-term neonates. This review will guide clinical practice as well as research to improve preterm and full-term neonates' pain management and prevent short-term and long-term complications caused by pain.Systematic review registrationPROSPERO CRD42017058021.

Project description:Background Intravenous paracetamol added to morphine reduces postoperative morphine consumption in (near)term neonates. However, there are only sparse data on intravenous paracetamol as multimodal strategy in extremely low birth weight (ELBW) neonates. Objectives This study aims to assess the effects of rescue intravenous paracetamol on postoperative pain management (≤48 h postoperatively) in relation to both analgesic efficacy (validated pain assessment, drug consumption, adequate rescue medication) and safety (hypotension and bradycardia). This rescue practice was part of a standardized pain management approach in a single neonatal intensive care unit (NICU). Methods A single-center retrospective observational study included 20 ELBW neonates, who underwent major abdominal surgery. The primary endpoints of the postoperative study period were pain intensity, over-sedation, time to first rescue analgesic dose, and the effect of paracetamol on opiate consumption. Secondary endpoints were safety parameters (hypotension, bradycardia). And as tertiary endpoints, the determinants of long-term outcome were evaluated (i.e., duration of mechanical ventilation, intraventricular hemorrhage - IVH, periventricular leukomalacia - PVL, postnatal growth restriction, stage of chronic lung disease – CLD or neurodevelopmental outcome according to Bayley-II Scales of Infant Development at 18–24 months). Results All neonates received continuous opioids (sufentanil or morphine) and 13/20 also intravenous paracetamol as rescue pain medication during a 48-h postoperative period. Although opioid consumption was equal in the non-paracetamol and the paracetamol group over 48 h, the non-paracetamol group was characterized by oversedation (COMFORTneo < 9), a higher incidence of severe hypotension, and younger postnatal age (p < 0.05). All long-term outcome findings were similar between both groups. Conclusions Our study focused on postoperative pain management in ELBW neonates, and showed that intravenous paracetamol seems to be safe. Prospective validation of dosage regimens of analgesic drugs is needed to achieve efficacy goals.

Project description:BackgroundAcutely painful procedures are commonplace. Current approaches to pain most often involve pharmacotherapy, however, there is interest in virtual reality (VR) as a non-pharmacological alternative. A methodologically rigorous systematic review and meta-analysis is lacking.MethodsFollowing PRISMA guidelines, we searched the Cochrane Library, Ovid MEDLINE, Embase, CINAHL, ERIC, NIHR Centre for Review and Dissemination, Proquest, the System for Information on Grey Literature in Europe and the WHO International Clinical Trials Registry Platform from inception to 5 November 2017. Included studies were randomised with an experimental trial design, included a non-VR control group and examined the efficacy of VR with regards to an acutely painful clinical intervention. Bias was assessed along Cochrane guidelines, with performance bias not assessed due to the non-blindable nature of VR. We extracted summary data for maximal pain score and used standard mean difference DerSimonian-Laird random-effects meta-analysis (RevMan 5.3). This review was prospectively registered (PROSPERO CRD42017058204).FindingsOf the 12,450 studies identified, 20 studies were eligible for the systematic review. No trials reported in sufficient detail to judge their risk of bias, and 10 studies were at high risk of bias in at least one domain. 16 studies (9 randomised controlled trials, 7 crossover studies) examining 656 individuals were included in quantitative synthesis. Pain scales were heterogenous, but mostly employed 100-point scales. Across all trials, meta-analysis was suggestive of a -0.49 (95%CI -0.83 to -0.41, p = 0.006) standardised mean difference reduction in pain score with VR. However there was a high degree of statistical heterogeneity (χ2 p<0.001, I2 81%, 95%CI for I2 70-88%), driven by randomised studies, with substantial clinical heterogeneity.ConclusionThese data suggest that VR may have a role in acutely painful procedures, however included studies were clinically and statistically heterogenous. Further research is required to validate findings, establish cost efficacy and optimal clinical settings for usage. Future trials should report in accordance with established guidelines.

Project description:ObjectivesTo evaluate the effects of white noise on pain-related cortical response, pain score, and behavioral and physiological parameters in neonates with procedural pain.MethodsA double-blind, randomized controlled trial was conducted. Sixty-six neonates from the Neonatal Intensive Care Unit in a university-affiliated general hospital were randomly assigned to listen to white noise at 50 dB (experimental group) or 0 dB (control group) 2 min before radial artery blood sampling and continued until 5 min after needle withdrawal. Pain-related cortical response was measured by regional cerebral oxygen saturation (rScO2) monitored with near-infrared spectroscopy, and facial expressions and physiological parameters were recorded by two video cameras. Two assessors scored the Premature Infant Pain Profile-Revised (PIPP-R) independently when viewing the videos. Primary outcomes were pain score and rScO2 during arterial puncture and 5 min after needle withdrawal. Secondary outcomes were pulse oximetric oxygen saturation (SpO2) and heart rate (HR) during arterial puncture, and duration of painful expressions. The study was registered at the Chinese Clinical Trial Registry (ChiCTR2200055571).ResultsSixty neonates (experimental group, n = 29; control group, n = 31) were included in the final analysis. The maximum PIPP-R score in the experimental and control groups was 12.00 (9.50, 13.00), 12.50 (10.50, 13.75), respectively (median difference -0.5, 95% CI -2.0 to 0.5), and minimum rScO2 was (61.22 ± 3.07)%, (61.32 ± 2.79)%, respectively (mean difference -0.325, 95% CI -1.382 to 0.732), without significant differences. During arterial puncture, the mean rScO2, HR, and SpO2 did not differ between groups. After needle withdrawal, the trends for rScO2, PIPP-R score, and facial expression returning to baseline were different between the two groups without statistical significance.ConclusionThe white noise intervention did not show beneficial effects on pain-related cortical response as well as pain score, behavioral and physiological parameters in neonates with procedural pain.

Project description:BackgroundOrally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.MethodsA total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.ResultsThere was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention.ConclusionsThe minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.Trial registrationClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

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

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

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