Paracetamol In Children Research Articles

Assessment of Paracetamol Usage Practices and Perceptions among Caregivers for Children Post-COVID-19 in Saudi Arabia: A Cross-Sectional Analysis.

Caregivers often use paracetamol in the management of pediatric illnesses without a clear rationale. This study evaluated the perception and practices of caregivers regarding the use of paracetamol in children in Southwestern Saudi Arabia. This study involved a cross-sectional design involving 373 caregivers of children under twelve. The questionnaire elucidated the reasons, usage frequency, and safe usage practices. Data were analyzed using SPSS, applying Chi-square tests and logistic regression. Most caregivers were in the age range of 31-40 years, and with intermediate education. Paracetamol was mainly used for fever, generalized pain and, diarrhea, with fewer opting for other self-care measures. Caregivers with primary or less education were more likely to perceive paracetamol as safe (AOR = 2.98 (1.3-6.73), p = 0.009) and less inclined to check warning labels (AOR: 0.11 (0.05-0.25), p < 0.001) and expiry dates (AOR: 0.063 (0.027-0.14), p < 0.001). The caregiver's education level significantly influenced the determination of treatment duration (χ2 = 21.58 (4), p < 0.001), dosage (χ2 = 30.70 (4), p < 0.001), and frequency of administration (χ2 = 17.77 (4), p = 0.001). In conclusion, inadequate health literacy can result in a lack of attention towards crucial safety information about pediatric paracetamol use. Hence, counselling initiatives should be undertaken to ensure the safe and effective use of paracetamol in children.

Medication errors involving intravenous paracetamol in children: experience from enquiries to the National Poisons Information Service

IntroductionChildren are at higher risk of medication errors due to the complexity of drug prescribing and administration in this patient group. Intravenous (IV) paracetamol overdose differs from overdose by ingestion...

Optimisation of acute pain treatment in children in abdominal surgery at the stages of the perioperative period

The aim of the study. To improve the quality of perioperative analgesia by combined multimodal use of paracetamol and ketorolac tromethamine in children after abdominal surgery.&#x0D; Materials and methods. 48 children (6-17 years old) with choledochal, pancreatic cysts, hepatic echinococcosis, and abdominal trauma. The study period was from January 2021 to January 2022. Group 1 (main group, n=28): baseline analgesia - 15 min before surgery, intravenous paracetamol administration at 25-30 mg/kg. In order to prevent postoperative pain syndrome 15 minutes before the end of the surgery, we administered ketorolac and tromethamine in a dose of 0.5 mg/kg. Pain relief was repeated 6-8 h later with ketorolac at a dose of 0.5 mg/kg. Group 2 (comparison, n=20), who received 0.2 – 0.3 mg/kg promedol (trimeperidin) in the postoperative period. Both groups received standard endotracheal anaesthesia (propofol + fentanyl + arduan against the background of Low-flow anaesthesia with sevoflurane MAK=1). Systemic haemodynamics, C-reactive protein, and glucose were investigated, and a visual analogue scale was applied at the main stages of the study.&#x0D; Results: Analysis of the parameters of central hemodynamics, parameters of the operational stress response and clinical data showed that in the postoperative period, sufficient analgesic effect was established only in children in group 1 with the preventive combined administration of paracetamol and ketorolac on the operating table, which allows recommending them in the practice of perioperative analgesia during abdominal surgical interventions.&#x0D; Conclusions. Optimised method of preventive (preoperative) use of paracetamol in children at a dose of 25-30 mg/kg during abdominal surgery followed by administration of ketorolac tromethamine (15 minutes before the end of the surgery) increases the degree of nociceptive protection. It ensures high efficiency of postoperative pain relief, which allows to recommend it in the practice of perioperative analgesia for the above abdominal surgical interventions in children

Prevalence of chronic pain after herniorrhaphy, orchiopexy, and bernardi procedure in children. A retrospective-prospective study

Chronic postsurgical pain (CPSP) is defined as pain that develops or increases in intensity after a surgical procedure and persists for at least three months. Its prevalence rate ranges from 5% to 54%. Aim - to assess the prevalence of CPSP among children at the age of 7-18 years residing in the Precarpathian region at three and six months after herniorrhaphy, orchiopexy and Bernardi procedure. Materials and methods. There were observed 92 children at the age of 7-18 years, who underwent treatment for abdominal wall hernia, cryptorchidism, varicocele, and hydrocele at the surgical department. Children were divided into the following groups: Group 1a included children at the age of 7-12 years with acute pain syndrome in the postoperative period; Group 1b comprised children at the age of 13-18 years with acute pain syndrome in the postoperative period; Group 2a included children at the age of 7-12 years with chronic pain syndrome; Group 2b included children at the age of 13-18 years with chronic pain syndrome. Results. The prevalence of CPSP following surgery among children of the Precarpathian region was found to be 33.7%, with a male predominance (р&lt;0.05). There was an increased need for postoperative pain management with paracetamol in children of Group 2a (р&lt;0.05). The mean scores of the Face, Legs, Activity, Cry, Consolability (FLACC) scale were significantly higher in children of Group 2a, 2b as compared to Group 1a, 1b (р&lt;0.05). The Visual Analogue Scale (VAS) confirmed greater pain intensity in children of Group 2a on the second and third days of treatment (р&lt;0.05). Conclusions. The high prevalence of chronic pain in children after herniorrhaphy, orchiopexy by Petrivalsky / Schoemaker technique, Ross and Bernardi procedures is due to ineffective perioperative pain management that requires the use of additional analgesia techniques, including regional ones. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Клинический случай токсического гепатита при применении парацетамола у новорожденного ребенка

Drug-induced liver injury is a rare but life-threatening phenomenon. Paracetamol is referred to as a drug with a direct dose-dependent hepatotoxic eff ect. Th e use paracetamol, even in therapeutic doses, is essentially safe, but requires a sensible approach while prescribing it to the risk groups and “off - label”. Th e use of paracetamol in children is limited at the age of less than 3 months. Signifi cant damage to hepatocytes by paracetamol in children is relatively rare and only occurs in 10% of the cases while taking potentially toxic doses of the drug. We have recorded a clinical case of toxic hepatitis development in a newborn aft er intravenous “off -label” administration of therapeutic doses of paracetamol in order to relieve the pain syndrome. Th is case is indicative of the fact that even therapeutic doses of paracetamol, as well as the predominantly sulfate pathway of drug biotransformation, which is typical for children under 14 years of age, does not rule out the possibility of toxic drug-induced liver damage. Taking into account the described case, there is a need to determine clear indications for “off -label” use of the drug in view of the possible toxic eff ect development.

SMA - TREATMENT: EP.275 Pharmacokinetics and safety of treatment with paracetamol in children and adults with spinal muscular atrophy

SMA - TREATMENT: EP.275 Pharmacokinetics and safety of treatment with paracetamol in children and adults with spinal muscular atrophy

Is paracetamol responsible for fatal acute liver failure in pediatric patients after hip dysplasia surgery?

It is well known that local complications, such as avascular necrosis and arthrosis can develop after surgery for developmental dysplasia of the hip (DDH). Thus far, systemic complications that may develop in such cases have not been identified in the literature. This study is the first case series to evaluate acute liver failure (ALF) development after DDH surgery in pediatric patients. Six patients, five female and one male, who underwent DDH surgery were selected for this study. Perioperative fasting time, laboratory values, treatments, histopathological evaluations, and prognoses after ALF in these patients were evaluated retrospectively. All the patients were administered paracetamol and sevoflurane in therapeutic doses. The patients were referred postoperatively to our pediatric emergency department after 5 ± 1.67 days (range = 3-7 days) on average. The average perioperative fasting time was 9.3 ± 0.82 hours (range = 8-10 hours). Due to the very high aminotransferases and use of paracetamol, intravenous N-acetylcysteine was administered alongside supportive treatments to all the patients. After liver transplantation, two of three patients with grade 3 encephalopathy, died in the early postoperative period. Histopathological evaluations of the three patients' explants were compatible with toxic hepatitis due to paracetamol. Paracetamol is a commonly used analgesic after pediatric surgery. The therapeutic dose of paracetamol remains uncertain in children who have been fasting for a long time and have been exposed to hepatotoxic drugs due to previous surgery. In conclusion, caution should be exercised in the use of paracetamol in children with DDH who will undergo surgery, and careful perioperative clinical and laboratory monitoring for ALF is essential.

Intravenous paracetamol for neonates: long-term diseases not escalated during 5 years of follow-up

ObjectiveTo evaluate the long-term adverse reactions of paracetamol in children who required intensive care shortly after birth. Paracetamol is a widely used analgesic in neonates, but the long-term studies are...

Practical Challenges-Use of Paracetamol in Children and YouthWho are Overweight or Obese: A Narrative Review.

Worldwide, > 380 million children and adolescents are overweight or obese, including 41 million children aged < 5 years. Obesity can change the pharmacokinetic properties of drugs by altering their distribution, metabolism, and elimination. Thus, children who are overweight or obese are at increased risk for receiving inappropriate doses of commonly used drugs, which can result in treatment failure, adverse events, and/or drug toxicity. This review analyzes available data on paracetamol dosing for pain and fever in children and adolescents who are overweight or obese to identify gaps and challenges in optimal dosing strategies. Literature searches using Medline, Embase, and ClinicalTrials.gov were conducted to identify English-language articles reporting paracetamol pharmacokinetics, dosing practices, and guidelines in children and adolescents who are overweight or obese. Of 24 relevant studies identified, 20 were specific to overweight/obese individuals and 15 were specific to children and/or adolescents. Data on paracetamol pharmacokinetics in children and adolescents who are overweight or obese are lacking, and there is no high-quality evidence to guide paracetamol prescribing practices in these patients. Adult data have been extrapolated to pediatric populations; however, extrapolation does not address differences in paracetamol metabolism in adults versus children; the efficacy and safety effects of such differences are unknown. Given the growing worldwide prevalence of obesity in children and adolescents and the likelihood that paracetamol use in this population will increase accordingly, obesity-specific pediatric dosing guidelines for paracetamol are urgently needed. High-quality research is necessary to inform such guidelines.

Effects of Ultrasound-Guided Thoracic Paravertebral Block on Postoperative Pain in Children Undergoing Percutaneous Nephrolithotomy.

To compare the effects of ultrasound-guided thoracic paravertebral block (PVB) and intravenous paracetamol on postoperative pain control in paediatric patients undergoing percutaneous nephrolithotomy (PNL). Forty patients aged 1-5 years, with an American Society of Anesthesiologists physical status I-II, scheduled for PNL were enrolled into this prospective randomised controlled trial. After arrival in the operating room, all patients were administered standardised general anaesthesia. Patients in Group PVB received ultrasound-guided PVB using bupivacaine 0.5% at a total volume of 0.5 mL kg-1 at the vertebral levels T11, T12 and L1. Patients in Group P were administered paracetamol intravenously (15 mg kg-1) before the beginning of surgery. Patients in both groups were given tramadol (1 mg kg-1) for supplemental analgesia. Patient demographics, haemodynamic parameters, peripheral oxygen saturation and sevoflurane concentration were recorded. The Face, Legs, Activity, Cry and Consolability pain scores; satisfaction of parents; the number of patients requiring supplemental analgesia; and complications were evaluated during the postoperative period. Pain scores were significantly lower in Group PVB compared with Group P (p=0.001). There were no analgesic requirements in Group PVB; however, all patients needed a supplemental analgesic in Group P. Parental satisfaction was higher in Group PVB than in Group P. This study demonstrated that ultrasound-guided PVB provides more effective postoperative analgesia with no side effects compared to intravenous paracetamol in children undergoing PNL.

Faster recovery and reduced paracetamol use \u2013 a meta-analysis of EPs 7630 in children with acute respiratory tract infections

ObjectiveFever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB).DesignMeta-analysis of randomised, placebo-controlled clinical trials.MethodsWe searched clinical trial registries (ISRCTN, ClinicalTrials.gov) and medical literature (MEDLINE, EMBASE), for randomised, placebo-controlled trials investigating the administration of EPs 7630 to children with ATP or AB and reporting the co-administration of paracetamol. Based on the individual participant data of the eligible trials, study populations were characterized according to sex and age, and meta-analyses were performed for cumulative paracetamol use and ability to attend school at treatment end.ResultsSix trials including a total of 523 children aged 6–10 years (EPs 7630: 265; placebo: 258) and suffering from non-β-hemolytic streptococcal ATP (3 trials) or from AB (3 trials) were identified and eligible. Children received EPs 7630 or placebo for 6 (ATP) or 7 days (AB). Compared to placebo, EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges’ g; − 0.28; 95% confidence interval: [− 0.53; − 0.02]; p < 0.03). At treatment end, 30.2% (EPs 7630) and 74.4% (placebo) of the children were still unable to attend school (risk ratio: 0.43; 95% confidence interval: [0.29; 0.65]; p < 0.001).ConclusionsIn children aged 6–10 years with AB or ATP, EPs 7630 alleviated the symptom burden and accelerated recovery. Although EPs 7630 has no known antipyretic effect, concomitant use of paracetamol was reduced.

Caregivers’ knowledge about children's paracetamol

AbstractAlthough safe, paracetamol, commonly used in children, can cause adverse events if not administered correctly. This research aimed to investigate caregivers' knowledge about children's paracetamol. A convenience sample of caregivers who had purchased Children's Panadol were asked to complete an online survey, assessing their knowledge of paracetamol. Most of the 174 respondents were female (93.7%), highly‐educated (72.4%) with adequate functional health literacy (85.6%). Almost all respondents correctly identified that Children's Panadol contained paracetamol (96.6%). However, approximately a quarter of them did not know the maximum daily dose (26.4%), just under half (46%) did not know how many days this dose could be safely given, and over one‐third (37.4%) did not know that liver toxicity could result from overdose. These findings suggest that adult caregivers administering paracetamol to children have gaps in their knowledge. Strategies to help improve caregiver's knowledge about the correct and safe administration of children's paracetamol need to be considered.

Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial

BackgroundMorphine is worldwide the analgesic of first choice after cardiac surgery in children. Morphine has unwanted hemodynamic and respiratory side effects. Therefore, post–cardiac surgery patients may potentially benefit from a non-opioid drug for pain relief. A previous study has shown that intravenous (IV) paracetamol is effective and opioid-sparing in children after major non-cardiac surgery. The aim of the study is to test the hypothesis that intermittent IV paracetamol administration in children after cardiac surgery will result in a reduction of at least 30% of the cumulative morphine requirement.MethodsThis is a prospective, multi-center, randomized controlled trial at four level-3 pediatric intensive care units (ICUs) in the Netherlands and Belgium. Children who are 0–36 months old will be randomly assigned to receive either intermittent IV paracetamol or continuous IV morphine up to 48 h post-operatively. Morphine will be available as rescue medication for both groups. Validated pain and sedation assessment tools will be used to monitor patients. The sample size (n = 208, 104 per arm) was calculated in order to detect a 30% reduction in morphine dose; two-sided significance level was 5% and power was 95%.DiscussionThis study will focus on the reduction, or replacement, of morphine by IV paracetamol in children (0–36 months old) after cardiac surgery. The results of this study will form the basis of a new pain management algorithm and will be implemented at the participating ICUs, resulting in an evidence-based guideline on post-operative pain after cardiac surgery in infants who are 0–36 months old.Trial registrationDutch Trial Registry (www.trialregister.nl): NTR5448 on September 1, 2015. Institutional review board approval (MEC2015–646), current protocol version: July 3, 2017

Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children.

Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children.

Pharmacokinetics of Single Dose Intravenous Paracetamol in Children

A new intravenous formulation containing paracetamol is now available and widely used in chil-dren, but with limited paediatric pharmacokinetic data. This study was aimed at determining the effects of age on the pharmacokinetics (PK) of this formulation of paracetamol in children. Blood samples were obtained from 24 children at 0, 15, 30 minutes, then 1, 2, 4, 6 and 8 hours after the administration of 15 mg kg-1 of IV paracetamol. Paracetamol was quantified using an HPLC-UV method, with lower limit quantification of 2200 pg and an intra-assay coefficient of variation of 3%. In the paediatric age groups 2-5 years, 6 -10 years and 11-14 years, total clearance (CLt) in kg l-1h-1, was 0.41(0.20–0.57), 0.31(0.14–1.10) and 0.37(0.09–0.55) respectively; volume of distribution (Vd) in litres was 0.90(0.7-1.1), 0.95(0.7-1.6) and 0.90(0.4 -1.3) respectively; and elimination half-lives (t1/2) in hours was 1.7(1.1-2.6), 2.2(0.6-3.5) and 1.6(1.1-4.7), respectively. The PK parameters (CLt, Vd and t1/2) obtained did not differ significantly among the paediatric age groups (the p- value in all cases was greater than 0.05). In children 2-14 years, there were no significant relationships between the PK parameters and age, weight, height, body weight or body surface area.Keywords: Acetaminophen, injection, pharmacokinetics, children, Ghana

Anaphylaxis to Paracetamol in a Twelve-Year-Old Girl

Paracetamol (acetaminophen) is widely used and considered safe, since adverse reactions to this drug in therapeutic doses are rare, especially in children.1,2 Only a few cases worldwide of anaphylaxis to paracetamol in children have previously been described.2-11 Anaphylaxis is defined as a life-threatening reaction resulting from mast cell derived mediator release.12 This report illustrates a case of anaphylaxis to oral paracetamol confirmed by an oral provocation test and an increase in serum tryptase level.

P242 Managing Etiology Questions With Grade

BackgroundCurrently the GRADE approach only considers the development of recommendations for treatment and diagnosis related clinical questions.ObjectivesTo develop a proposal using GRADE to formulate recommendations for aetiology questions.MethodsThe exposure to...

Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study

Paracetamol is the most commonly administered medicine to children. A recent study highlighted the risk of overdose of paracetamol using British National Formulary for Children (BNFC) age-based dosing guidelines. This current study assesses the safety of changes to the UK paracetamol product dosing system proposed by the Medicines and Healthcare products Regulatory Authority (MHRA) which include a larger number of narrower age bands and a single dose per age band. Theoretical comparison of the proposed MHRA dosing system with the product dosing instructions of a commonly prescribed form of paracetamol in the UK. United Kingdom Participants Proposed MHRA dosing recommendations and current product dosing instructions were compared using a previously validated model. For both dosing recommendations, single and cumulative daily doses of paracetamol for boys and girls at the 9th, 50th and 91st centiles for weight were calculated for 3 month, 1 year, 6 year and 12 year age groups. With the current product dosing instructions, underweight children are at risk of receiving approximately two times the recommended single and cumulative daily dose of paracetamol, particularly at age 1 year and 6 years. This risk is negligible when the same model is applied to the proposed MHRA dosing system, whereby underweight, average weight and overweight children at all ages receive doses marginally above or within the recommended dose range or limit. The proposed MHRA dosing recommendations for paracetamol use in children are effective at reducing the risk of paracetamol overdose in children of all ages, when compared with current product dosing instructions.

Population pharmacokinetics of single-dose intravenous paracetamol in children

To determine the pharmacokinetics (PK) of a new i.v. formulation of paracetamol (Perfalgan) in children ≤15 yr of age. After obtaining written informed consent, children under 16 yr of age were recruited to this study. Blood samples were obtained at 0, 15, 30 min, 1, 2, 4, 6, and 8 h after administration of a weight-dependent dose of i.v. paracetamol. Paracetamol concentration was measured using a validated high-performance liquid chromatographic assay with ultraviolet detection method, with a lower limit of quantification (LLOQ) of 900 pg on column and an intra-day coefficient of variation of 14.3% at the LLOQ. Population PK analysis was performed by non-linear mixed-effect modelling using NONMEM. One hundred and fifty-nine blood samples from 33 children aged 1.8-15 yr, weight 13.7-56 kg, were analysed. Data were best described by a two-compartment model. Only body weight as a covariate significantly improved the goodness of fit of the model. The final population models for paracetamol clearance (CL), V(1) (central volume of distribution), Q (inter-compartmental clearance), and V(2) (peripheral volume of distribution) were: 16.51×(WT/70)(0.75), 28.4×(WT/70), 11.32×(WT/70)(0.75), and 13.26×(WT/70), respectively (CL, Q in litres per hour, WT in kilograms, and V(1) and V(2) in litres). In children aged 1.8-15 yr, the PK parameters for i.v. paracetamol were not influenced directly by age but were by total body weight and, using allometric size scaling, significantly affected the clearances (CL, Q) and volumes of distribution (V(1), V(2)).

A03 Preemptive Analgesia with Paracetamol in Pediatric Neurosurgical Patients

Objective: to investigate the effectivness of preemptive analgesia with rectal paracetamol in children undergone neurosurgical interventions. Methods: with informed consent from parents we enrolled 16 children under 1 year underwent ventriculo-peritoneostomy. Monitoring included pulse oximetry, HR, ECG, NIBP, ETcapnography (Nihon Kohden, Siemens KION). Premedication: oral midazolam (0,08 mg/kg); total intravenous anesthesia: fentanyl (3, 5 mcg/kg/h), propofol (2, 5 mcg/kg/h); neuromuscular block: pipecuronium (0,1 mg/kg). Patients received preemptive analgesia with rectal paracetamol before incision (10 mg/kg). In postoperative period all the patients had been receiving rectal paracetamol (10 mg/kg) every 8 hours for two days. Blood samples were taken before anesthesia induction, during the operation and the next morning. We investigated prolactine, cortisol levels (IMMULITE). Also we assessed patient's pain with biobehavioral scales (NIPS, CHIPPS, CRIES). Results: before operation there were age-related normal hormone levels. We observed intraoperative increase of prolactine concentration. On the 1st postoperative day prolactine concentration decreased significantly comparing to intraoperative levels. Levels of cortisol during anesthesia and on the first postoperative day also decreased comparing to preoperative levels. There was a statistically significant difference (P < 0,05) between preoperative and postoperative levels of stress hormones. Biobehavioral scales in postoperative period showed 0–2 grades in all patients that indicated pain absence. Conclusion: decreasing of stress-hormones levels demonstrated that the preemptive analgesia with rectal paracetamol provides physiologically appropriate level of postoperative analgesia after neurosergical operations in children.