Intravenous Acetaminophen Process Over Oral Acetaminophen Project

Intravenous Acetaminophen Process Over Oral Acetaminophen Project Intravenous Acetaminophen Process Over Oral Acetaminophen Project Need help with my Article Writing question – I’m studying for my class. Should be written in 2 pages or less. APA format evidence_base_practice_project_and_presentation.docx roy_simalti2018_article_comparisonofantipyreticefficac.pdf ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS Evidence Base Practice Project and Presentation NURS 4431 students are required to complete an evidence base practice project including presenting the project to the clinical group or class. The evidence base practice project should use the PICO tool to identify the population of interest, identify an intervention to improve the identified clinical problem, compare how the intervention will be an improvement over the current situation, and describe the intended outcome and how the outcome will be measured/evaluated. Additional information about the evidence base practice project is located in the clinical materials section of blackboard. The project and presentation may be an individual or small group (2-3 students) project. Every student in the group must have two (2) peer reviewed nursing journal articles from the United States and less than five (5) years old. The goal is for you to identify a clinical problem or concern and identify an intervention to address the issue. It can be anything from discharge instructions, mapping in the hospital to find the location of clinics, etc, asking questions of the provider, etc. Identify the problem [hospital mapping to clinics or other locations in the hospital are confusing, only in 1 language, non-compliant for visually impaired populations], intervention [add a directory to locations in the facility with color coding then color coded lines on the floor to aid in following the lines to assist with finding the location], comparison [the intervention is low cost and can improve satisfaction compared to other possible interventions], and outcome [outcome satisfaction can be measured by adding a question to the current patient satisfaction surveys asking if the mapping was beneficial]. The presentation must be typed using APA format. The project must be presented orally to the clinical group or during the final day of class. The project must also be uploaded to blackboard. Each student in the small group must upload their project. Students may do their presentation as a power point poster presentation in addition to the typed project. The project and presentation count for two (2) clinical hours. Indian J Pediatr (January 2018) 85(1):1–4 DOI 10.1007/s12098-017-2457-3 ORIGINAL ARTICLE Comparison of Antipyretic Efficacy of Intravenous (IV) Acetaminophen versus Oral (PO) Acetaminophen in the Management of Fever in Children Shuvendu Roy 1 & A. K. Simalti 1 Received: 29 March 2017 / Accepted: 9 August 2017 / Published online: 9 September 2017 # Dr. K C Chaudhuri Foundation 2017 Abstract Objective To assess the dynamics of the onset of antipyretic efficacy of intravenous (IV) acetaminophen vs. oral (PO) acetaminophen in the management of fever in children. Methods This observational single-dose study was conducted at Department of Pedriatrics, Army Hospital (Research and Referral), a multispecialty tertiary care center in New Delhi in fever patients to assess the antipyretic efficacy of IV acetaminophen 15 mg/kg/dose vs. PO acetaminophen 15 mg/kg/dose over 6 h. Subjects were randomly assigned to receive either IV acetaminophen (n = 200) or PO acetaminophen (n = 200). Results Demographics and baseline characteristics were similar between the two groups and were normally distributed. Allergic reaction was found in 7 (3.5%) patients in IV acetaminophen group and was absent in PO acetaminophen group. Onset of constipation and dry mouth was found in 8 patients (4%) in IV acetaminophen group and was absent in PO acetaminophen group. Additional dose was required in 6 patients (3%) in intravenous acetaminophen group and 10 patients (5%) in oral acetaminophen group respectively. Statistically significant differences in the rate of fall in temperature through 180 min were observed in favor of the IV acetaminophen group when compared to those receiving PO acetaminophen. Conclusions A single dose of intravenous acetaminophen is safe and effective in reducing fever where patients are unable to tolerate oral administration or when rapid reduction of temperature is desirable. *NURS4431 Intravenous Acetaminophen Process Over Oral Acetaminophen Project A. K. Simalti [email protected] 1 Department of Pediatrics, Army Hospital (Research & Referral), New Delhi 110010, India Keywords Fever . Pediatrics . Acetaminophen . Paracetamol . Intravenous . Oral Introduction Fever is one of the commonest presenting symptoms in clinical medicine in all age group patients. It is defined as oral temperature of >37.2 °C (>98.9 °F) in the morning or >37.7 °C (>99.9 °F) in the evening [1]. Fever can be caused by a numerous ailments ranging from potentially serious conditions to very benign illness. Treatment with antipyretics not only reduces fever but also improves the associated other symptoms (e.g., ? arthalgia, myalgia, headache, nausea, vomiting) [2, 3]. Both pharmacologic and non-pharmacologic methods like tepid sponging [4] have been used to reduce body temperature in febrile patients. Extensive studies have been done in children comparing the efficacy of various antipyretics including paracetamol, ibuprofen, nimesulide, ketoprofen, propacetamol, and dipyrone. Among these, acetaminophen is considered safest antipyretic as well as analgesic and is the most widely used antipyretic. Per oral (PO) acetaminophen was first approved by the U.S. Food and Drug Administration (FDA) in the year 1951 and was marketed in 1953 in United States. Intravenous (IV) acetaminophen was first approved in Europe in 2001. As of now acetaminophen has received approval for short-term management of fever as well as acute pain in about 80 countries besides United States [5, 6]. Most of the available studies on acetaminophen were carried out in endotoxin-induced febrile models [7, 8] and in intensive care patients [9]. There is scarcity of literature on the effect of route of administration (oral and intravenous) on antipyretic efficacy of paracetamol in children. Therefore, the authors decided to compare the 2 antipyretic efficacy of oral and intravenous paracetamol in febrile children. Material and Methods It was a prospective observational study of one and a half year duration conducted in a tertiary care centre at New Delhi. Sample size was determined to be 200 and all admitted or out-patient department cases with fever more than 1030 F were included in study. Children who had received medicines with antipyretic effects within 48 h of admission were excluded from the study. Similarly, children with known hypersensitivity to acetaminophen or other NSAIDs, impaired liver function, active hepatic disease, or evidence of clinically significant liver and renal disease were also not included in the study. Necessary approval to conduct the study from the Institutional Ethics committee was taken. Informed consent of the parents of children was taken prior to enrolment in the study. Following receipt of consent, children were divided into two groups, one group receiving oral acetaminophen (15 mg/ kg/dose) and the other group receiving IV acetaminophen (15 mg/kg/dose) as antipyretic. Children were enrolled in each group consecutively. Baseline vital parameters including mean arterial pressure using non-invasive blood pressure monitor by oscillometric technique were recorded. Following administration of the drug the child was monitored for the primary efficacy outcome. Axillary temperature was recorded with mercury thermometer for 5 min every ½ hourly, till 6 h. Children were monitored for any evidence of intolerance. All the data including the primary and secondary outcomes were recorded. All the statistical analysis was performed using SPSS version 20. The clinical profile of patients was analyzed by Student t test (quantitative variables) and chi-square test (qualitative variables). Five percent probability level was considered to be statistically significant i.e., p < 0.05. Results A total of 400 participants were enrolled, allocated groups and subsequently received study intervention; 200 in intravenous acetaminophen arm and 200 in the oral acetaminophen arm. Baseline and demographics characteristics were similar in both the groups and were normally distributed with mean (±SD) age being 6.7 (±2.75) y. The mean weight was 23.3 (± 6.41) kg and the majority of subjects were boys (71%). The sex distribution was similar in both the groups (Table 1). Allergic reaction (rash,itching) was found in 7 patients in Intravenous acetaminophen group and was absent in oral acetaminophen group. Onset of constipation and dry mouth was found in 8 patients (4%) in intravenous acetaminophen group and was absent in oral acetaminophen group. Additional dose Indian J Pediatr (January 2018) 85(1):1–4 was required in 10 patients (5%) and in 6 patients (3%) in oral acetaminophen group and intravenous acetaminophen group respectively (Table 2). NURS4431 Intravenous Acetaminophen Process Over Oral Acetaminophen Project The present study revealed that intravenous acetaminophen brought a more rapid reduction of fever as compared to oral acetaminophen (Fig. 1). Statistically significant difference in the weighted sum of temperature differences (WSTD) in 180 min (p < 0.004) was noted in favor of the intravenous acetaminophen group as against the group receiving oral acetaminophen. Beyond 4 h, no difference in WSTD was found in both the groups (Fig. 1). Up to 4 h, the intravenous acetaminophen receiving children had lower mean temperatures overall, and maximum mean temperature 1 °C less than those who received oral acetaminophen between 0 to 180 min. It has been observed that although the basal temperature was found to be same in both the groups after 4 h of initiating the therapy, IV acetaminophen group experienced a faster descent of temperature in initial 2 h. A difference which was statistically significant in the reduction of maximum temperature was achieved during the duration T0 min to T240 min in the subjects who were given intravenous acetaminophen as compared to subjects who were given oral acetaminophen, while at point T240 and onwards, temperature reduction achieved same pattern in both groups. The faster decent in body temperature in IV group is presumably due to the pharmacokinetic superiority of an intravenous administration. However the temperature observed at the end of study period of 6 h was mainly similar in both the groups, suggesting the fact that IV acetaminophen brings down the temperature faster than the oral one. Discussion Fever is not a primary illness but a physiologic mechanism and has beneficial effects in fighting against infection. There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications. Thus, the primary goal of treating a febrile child should be to improve the child’s overall comfort rather than focus on normalization of body temperature. The most common indications for initiating antipyretic therapy by pediatricians are a temperature higher than 38.3 °C (101 °F) and improving the child’s overall comfort [10]. Most pediatricians observe, with some supporting data from research, that febrile children have altered activity, sleep, and behavior in addition to decreased oral intake [11]. Unfortunately, there is a paucity of clinical research addressing the extent to which antipyretics improve discomfort associated with fever or illness. Acetaminophen is synthetic, non-opioid, centrally acting antipyretic and analgesic agent [12]. It’s efficacy profile is well-established along with a safe risk vs. benefit ratio. Besides it is not associated with known harmful drug to drug Indian J Pediatr (January 2018) 85(1):1–4 3 Table 1 Baseline statistics of all cases Age (in years) Weight (in kg) HR (per min) RR (per min) Mean 6.7742 23.2975 118.4400 23.9200 Std. Error of Mean 0.19361 0.45287 0.65604 0.19637 Median Mode 6.2500 5.00 22.0000 20.00 122.0000 124.00 24.0000 24.00 Std. Deviation Percentiles 2.73807 6.40452 9.27776 2.77708 25 5.0000 18.0000 112.0000 22.0000 50 75 6.2500 9.0000 22.0000 28.0000 122.0000 126.0000 24.0000 26.0000 HR Heart rate; RR Respiratory rate Table 2 Comparison of adverse effects and need for additional dose Adverse effects Oral group (n = 200) IV group (n = 200) P value Rash, itching Constipation Dry mouth Additional dose requirement 0 0 0 10 7 8 8 6 0.0076 0.0043 0.0043 0.3074 factors which may include erratic placement of the suppository, variability in absorption from different preparations of suppositories, lipophilicity of rectal formulation, and the rectal pH at the time of administration. Thus, absorption from acetaminophen suppositories tends to be highly variable and gradual [16–18]. Higher doses given through this route may increase the risk of drug accumulation along with toxicity in children who absorb efficiently through rectal mucosa. Rectal administration of drugs may not be socially feasible in some scenarios (e.g., adolescent children, grown up girls). Central nervous system is an active site for the antipyretic effect of acetaminophen. Hence, cerebrospinal fluid (CSF) concentration would be more relevant as compared to plasma levels. NURS4431 Intravenous Acetaminophen Process Over Oral Acetaminophen Project The acetaminophen concentration– time curve of CSF correlates better than that of plasma. Both of these curves are similar except for the time lag to achieve CSF penetration [19]. In an earlier study comparing both of these routes of acetaminophen administration, the mean CSF concentration was observed to be almost 70% higher with IV route when compared to equivalent oral administration of acetaminophen [20]. Kumpulainen and colleagues [19] observed that while both, oral as well as rectal routes of acetaminophen administration were effective, IV acetaminophen led to faster achievement of peak plasma and CSF levels resulting in faster onset of action. Similar findings were observed in index study also. The faster antipyretic effect by IV administration leads to Mean Temperature (°F) interaction [13]. The present study revealed that intravenous acetaminophen brought a faster reduction of temperature as compared to oral acetaminophen. Statistically significant differences in the weighted sum of temperature difference (WSTD) through 180 min (p < 0.004) was seen in favor of the intravenous acetaminophen group as against the group receiving oral acetaminophen. However after 4 h, there seemed to be no difference in the WSTD between both the groups. Overall mean temperatures were lower in intravenous acetaminophen receiving group for four hours, with a maximum mean temperature 1 °C lower than the oral acetaminophen receiving group. It has been observed that although the basal temperature was found to be the same in both groups after 4 h of initiating the therapy, IV acetaminophen group experienced a faster decent of temperature in initial 2 h. The faster decent in body temperature in IV group is presumably due to the pharmacokinetic superiority of an intravenous administration. However the temperature observed at the end of study period of 6 h was mainly similar in both the groups – suggesting the fact that IV acetaminophen brings down the temperature faster than the oral one. Having the choice of an intravenous preparation of acetaminophen for management of fever can be particularly advantageous for children, where oral delivery may not be possible or feasible due to numerous practical pediatric issues (e.g., irritability, refusing to take medicine etc.) and in some morbid clinical conditions (e.g., oral intake is temporarily withheld as in post op scenarios). Acetaminophen can also be administered through rectal route. Although widely used, it is known to result in erratic and slow absorption [14, 15] because of several 105 104.5 104 103.5 103 102.5 102 101.5 101 100.5 100 99.5 99 98.5 98 97.5 97 Intravenous acetaminophen Oral acetaminophen Time post dose (min) Fig. 1 Time post dose mean temperature variation in the study groups 4 Indian J Pediatr (January 2018) 85(1):1–4 faster correction of fever related symptoms, like nausea and vomiting. This may also help in absorption of orally administered medications. It has also been observed in this study that adverse drug reactions were also very minimal in the study groups. In view of these observations, faster reduction of temperature by intravenous acetaminophen administration, it might be considered superior in children, especially in some specific pediatric ailments (e.g., febrile seizure, febrile encephalopathy, high fever with feed refusal) where faster reduction of fever is considered essential to prevent a scary convulsive attack or alarming metabolic compromise. 5. 6. 7. 8. 9. Conclusions 10. From the results of the present study, it may be concluded that a single dose of intravenous acetaminophen is safe and effective in reducing fever. Intravenous acetaminophen may be useful where patients are unable to tolerate oral administration or when rapid reduction of temperature is desirable. 11. Contributions SR: Concept, conducting study, manuscript preparation and revision; AKS: Data collection and manuscript preparation. SR will act as guarantor for the paper. Compliance with Ethical Standards 12. 13. 14. 15. Conflict of Interest None. 16. Source of Funding None. References 1. 2. 3. 4. Charles A, Dinarello PR. Fever and hyperthermia. In: Longo DL, Fauci A, Kasper D, Hauser S, Jameson J, Loscalzo J, editors.v Harrison’s principles of internal medicine. 18th ed. New York: McGraw-Hill; 2012. p. 143-7. Oborilová A, Mayer J, Pospísil Z, Korístek Z. Symptomatic intravenous antipyretic therapy: efficacy of metamizol, diclofenac, and propacetamol. J Pain Symptom Manag. 2002;24:608–15. Kramer MS, Naimark LE, Roberts-Brauer R, McDougall A, Leduc DG. Risks and benefits of paracetamol antipyresis in young children with fever of presumed viral origin. Lancet. 1991;337:591–4. Thomas S, Vijaykumar C, Naik R, Antonisamy B. Comparative effectiveness of tepid sponging and antipyretic drug versus only antipyretic drug in the management of fever among children: a randomized controlled trial. Indian Pediatr. 2009;46:133–6. 17. 18. 19. 20. Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69:101–13. Prescott LF. Paracetamol: past, present, and future. Am J Ther. 2000;7:143–7. Peacock WF, Breitmeyer JB, Pan C, Smith WB, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen compared to oral acetaminophen for the treatment of fever. Acad Emerg Med. 2011;18:360–6. Kett DH, Bretmeyer JB, Ang R, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen vs intravenous placebo for the treatment of fever. Clin Pharmacol Ther. 2011;90:32–9. Mullins ME, Empey M, Jaramillo D. A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients. Neurocrit Care. 2011;15:375–8. May A, Bauchner H. Fever phobia: the pediatrician’s contribution. Pediatrics. 1992;90:851–4. Mistry RD, Stevens MW, Gorelick MH. Short term outcomes of pediatric emergency department febrile illnesses. Pediatr Emerg Care. 2007;23:617–23. Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69:101–13. Pernerstorfer T, Schmid R, Bieglmayer C, Eichler HG, Kapiotis S, Jilma B. Acetaminophen has greater antipyretic efficacy than aspirin in endotoxemia: a randomized, double blind placebo controlled trial. Clin Pharmacol Ther. 1999;66:51–7. Coulthard KP, Nielson HW, Schroder M, et al. Relative bioavailability and plasma paracetamol profiles of Panadol suppositories in children. J Paediatr Child Health. 1998;34:425-31. Gaudreault P, Guay J, Nicol O, Dupuis C. Pharmacokinetics and clinical efficacy of intrarectal solution of acetaminophen. Can J Anaesth. 1998;35:149–52. Beck DH, Schenk MR, Hagemann K, Doepfmer UR, Kox WJ. 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