Intravenous Paracetamol to manage pain - Research Proposal Example

?Managing Postoperative Pain With Intravenous Paracetamol Patients are bound to experience pain after the effect of anaesthesia given beforesurgery is finally gone. White et al (2010) had reported a result of surveys in Europe and the USA, stating the need to improve the quality of managing pain after surgeries. The practice then was to use opioids which have multiple adverse effects (AEs): constipation, urinary retention, vomiting/nausea, allergic reactions, confusion, sedation, respiratory depression, and hypotension. These AEs increased the cost of hospitalization and delayed the recovery of patients. A better way of managing pain was then under clinical trials for 15 years. It involved the use of analgesics that require less opioids. There was no FDA approved Intravenous Acetaminophen at that time. Cadence Pharmaceuticals Inc. patented the first I.V. Paracetamol in July 8, 2011 (US SEC 2011) and produced Ofirmev which, until the present, does not have a competitor worldwide due to the recognized protection for intellectual property. This gathered evidence about the efficacy and safety of using Ofirmev (the only available US FDA approved Intravenous Acetaminophen in the market), how it benefits patients, and actually improved the quality of pain management. There were evidences based on actual clinical trials with patients that proved the efficacy and safety of Intravenous Paracetamol to neonates, infants, children, adolescents, adults, and even the elderly with age 65 years old and above, for mild, moderate, and severe cases of pain, especially postoperative pain. Introduction Focus is given to the extent of actual benefits observed in many clinical trials, limitations, and clarifications pertaining to the use of I.V. Paracetamol use for postoperative pain management. As a background, over a year after the introduction of the US FDA approved injectable pain reliever under the brand name Ofirmev, doctors have pursued further clinical trials in Europe and the USA covering thousands of patients. One of the references of this paper took the effort to search for registered clinical trials in order to learn more about efficacy, safety, proportion of patients who responded favourably or not, to mostly postoperative cases. It would be interesting to know under what conditions I.V. Acetaminophen should be administered to patients. What procedures were followed? Why? There are very young to very old patients who encounter the need for surgery. How should it be given? In actual experiences, was it safe to administer the use of this analgesic to any of such patients? What are the chances of having a satisfied postoperative patient after using Ofirmev? For one thing, doctors excluded patients with symptoms pointing to contraindications against the use of Intravenous Acetaminophen. These are situations wherein patients have severe liver disease, hepatic impairment and active hepatic disease, allergic to acetaminophen, chronic malnutrition, severe renal impairment, and to patients with history of being alcoholic. The US FDA (2012a) announced that the limitation per dosage of acetaminophen should be 325 mg. while the total maximum dosage per day must not exceed 4 grams. For infants, the recommended dose of the US FDA for acetaminophen in vial is only 50 mL per child weighing less than 33 kg. (US FDA 2012b, p.12) There were cases of acetaminophen over dosages in infants and adults in the past. For adults, from 1998 to 2003, a total of 131 people experienced “acute liver failure in the United States” due to acetaminophen overdose (US FDA 2012a). Nonetheless, the medical practice has changed from using mostly opioids like morphine and non-steroidal anti-inflammatory drugs (NSAIDs) to the preferred use of Intravenous Acetaminophen in combination with less opioids only when needed, for reasons that will be disclosed in this paper. Problem and Purpose Quality management of postoperative pain requires provisions for the comfortable recovery of patients right after surgery. Unfortunately, the use of opioids to act on the central nervous system (CNS) is like conditioning people to depend on narcotics for the elimination of pain, aside from leading them to experience the multiple AEs capable of preventing patients from returning to normal life (normal sleep, normal walking, normal socialization, normal work, and even normal eating). AEs were traced to the deteriorating effects of narcotics. Furthermore, cost of health care was higher as a result of experiencing the longer duration to recover from AEs. Side effects were recognized and reported to the California Association of Nurse Anaesthetics based on actual results of clinical trials (Yudt, 2012). And use of Intravenous Acetaminophen was reported to have resolved this problem up to a certain extent. The purpose of this research is to verify the evidences supporting claims about improvements in medical practice insofar as relieving pain and preventing it from being unbearable among postoperative patients. It takes officially reported results of clinical trials by doctors who actually performed surgeries and who had to find ways and means to ease the pain shortly after the anaesthetic effect on the CNS enables patients to feel the postoperative pain. Using such reported findings, this paper will describe the efficacy and safety of I.V. Acetaminophen for postoperative pain management, and then analyze some of the researched articles on the topic to find out how it actually improved the quality of pain management. Following are the questions that were answered: (1) What benefits did postoperative patients actually realize? (2) How many or what percentage of postoperative patients responded favourably or realized the benefits of Intravenous Paracetamol? And the secondary questions answered were: (3) How was the I.V. Acetaminophen administered safely? Or how was its safe use established? (4) Under what conditions was it safe to treat the pain of postoperative patients other than not having contraindication issues? Literature Review Frances Kolcaba’s Theory of Comfort states (De Chesnay, 2010, p.105) that nurses should give more attention to the patients’ need for comfort in various areas of human life – social, psychological, financial, spiritual, environmental, and physiological. By dwelling on the latest means of providing postoperative patients their need for a safer, less excruciating pain relief, this theory comes to mind. Intravenous Acetaminophen was noted for its efficacy in allowing patients to feel less pain even after the effect of anaesthesia lapses. It was also shown from actual clinical trials that the way to prevent too much feeling of pain is by considering the Neuman Theory which proves through observations that prevention is intervention (Finkelman, and Kenner, 2010, p. 70). More than a dozen scholarly materials are referred to in this effort to verify efficacy and safety of using Intravenous Acetaminophen. To establish the safety and efficacy of IV Paracetamaol, McMicol et al (2011, Summary) considered 3,896 patients in 36 researched studies involving controlled trials up to May 2010. The sources of data came from “Cochrane Central Register of Controlled Trials” in the 2nd quarter of 2010, from MEDLINE from 1950 up to May 2010, from EMBASE from 1980 to 2010, and from LILACS from 1992 up to May 2010. In addition, clinical trials at the registry of clinicaltrials.gov were also included. Children and adults who reported post-surgery operative pain (PSOP) with or without relief were included in the evaluation. These studies included clinical trials using IV paracetamol to control “acute postoperative pain in adults or children” (Summary). In those 36 studies, only 712 patients received I.V. paracetamol directly while 1,431 received paracetamol with propacetamol; 705 received NSAID or opioid. Apparently, clinical trials involving propacetamol were outside of the USA because Propacetamol was never approved by the US FDA (Yudt, 2012, p.7). During the search, doctors were looking for pain intervention within 4-6 hours. Two ways of paracetamol administration were observed. One way of administering with paracetamol was by hydrolysing 2 grams of proparacetamol with 1 gram of paracetamol. Then the formula is injected into the liquids connected intravenously. This causes pain on the injection site. But with a ready-to-use IV paracetamol, there was negligible discomfort for the patients. Interventions started within 30 minutes prior to the end of surgical procedures. To be accurate about their understanding of findings reported, these doctors went to the extent of contacting the medical team involved in the operation just to clarify some information. The data gathered were categorized under primary or secondary results. Primary referred to pain, intensity of pain, and pain relief. Secondary results included the need for rescue medications, duration and time of rescue, consumption of opioid, and others. More specifically, the desired primary result pertained to (1) the number of patients who experienced at least 50% pain relief in proportion to the total sample size with the 4th hour after surgery and in the 6th hour after surgery, and (2) the proportion of patients who had to be treated in order to benefit from the 50% pain relief of paracetamol intervention during the 4th to 6th hour after operation. Conclusions arrived at were as follows: (1)Definitely, paracetamol whether intravenous paracetamol or hydrolysed with propacetamol had superior benefits compared to placebo. (2)40% of those given paracetamol with propacetamol or 166 / 415 experienced 50% pain relief for 4 hours. (3)32% of those given I.V. paracetamol or 74 / 232 experienced 50% pain relief. (4)16% of those receiving placebo 0r 66 / 425 experienced 50% pain relief. (5)In terms of number needed to be treated and to benefit (NNTB), 1 / 4 had to be treated with paracetamol in order to realize 50% pain relief during the 4 hours. This would represent the proportion of patients who could not withstand the pain with just a placebo. (6)Within the duration of 6 hours, 26% or 91 / 344 of those given paracetamol with propacetamol continued to experience at least 50% pain relief. (7)Within the duration of 6 hours, 27% or 63 / 232 of those injected with I.V. paracetamol continued to experience at least 50% pain relief. (8)For those under paracetamol which was administered in any one of the two ways, 59% required rescue medication, versus the 77% of those treated with placebo. (9)In terms of the use of opiod, those under placebo needed 4.4 mg. of morphine which was 1.3 mg more than the requirement of morphine for paracetamol-treated patients. (10)The difference in pain relief for Propacetamol + Intravenous Paracetamol (PIP) versus direct I.V. Paracetamol was found to be insignificant. However, in the process of infusion to patients, the use of Propacetamol hydrolysed with I.V. Paracetamol caused more pain. It caused even more pain than when placebo was infused (p.768). (11)In three (3) studies comparing NSAIDs with PIPs, only 1 % of patients experienced hypotension when PIP was used, while 10% of those who used non-steroidal anti-inflammatory drugs (NSAIDs) had hypotension for the adverse effects (AE). (12)Another significant AE was the Gastro-intestinal Disorder (GID) wherein only 11% of PIP users reported this AE, while 42% of those who used NSAIDs experienced the same GID. (13)Propacetamol + Intravenous Paracetamol (PIP) and purely I.V. Paracetamol are similarly effective and safe, ”with the exception of the incidence of pain” (p.772) as a result of infusion using the PIP alternative instead of purely I.V. paracetamol. There was less pain when only I.V. paracetamol was utilized. Wininger et al (2010, Abstract) also proved efficacy and safety of I.V. Acetaminophen in a double-blind study of 4 groups in 17 locations in the USA for postsurgical abdominal laparoscopy patients. IV acetaminophen was given with a dosage of 1 g in 6 hours and another group given 650 mg in 4 hours showed efficacy while the group with placebo felt the moderate to severe pain after abdominal laparoscopy. In a clinical study involving the use of Ofirmev for adolescents, children, infants, and neonate, to test the efficacy of intravenous acetaminophen against fever or pain, Zuppa et al (2012) verified the safe use of Intravenous Acetaminophen. Dosages administered were as follows: Dosages of Ofirmev Neonates (less than 29 days old) 12.5 mg./kg. b.w. per 6 hours or 15 mg/kg. b.w. per 8 hours Infants ( 29 days up < 2 years old) 12.5 mg/kg. b.w. per 4 hours or 15 mg/kg b.w. per 6 hours Children ( 2 yrs. Old to < 12 ) 12.5 mg/kg. b.w. per 4 hours or 15 mg/kg b.w. per 6 hours Adolescents (> 12 years old) 12.5 mg/kg. b.w. per 4 hours or 15 mg/kg b.w. per 6 hours The conclusion arrived at was favourable for all the young patients. Ofirmev was well tolerated and proven to be safe at such dosages aside from being potent as analgesic and to treat fever. Jahr et al (2012, Abstract) studied the effects of using I.V. Paracetamol on 107 elderly patients who were 65 years old and above. They were able to conclude that IV Acetaminophen was effective and safe as pain reliever for postoperative patients. The potency of effect was the same as that experienced by patients younger than 65 years old. Hong, Kim, Chung, Yun, and Kil (2010) reviewed a clinical trial that was conducted to determine if repeated IV paracetamol administration would decrease postoperative pain. Participants included 124 women, ages 21-60 years old, who had electively scheduled robot-assisted endoscopic thyroidectomy via the transaxillary approach. Participants were randomized into a study group or a control group. The study group received IV paracetamol before anesthesia and then again at six hour intervals for the 24 hours following surgery. The control group received a placebo. Among study group participants, postoperative pain scores were significantly lower at one hour, three hours, six hours, and 24 hours postoperatively, when compared to the postoperative pain scores in the control group. Additionally, a statistically significant smaller number of study group participants (9.5%) required rescue analgesics when compared to the control group (65.6%). Postoperative nausea and vomiting also occurred more often among those in the control group when compared to the study group. Postoperative side effects (such as sedation and confusion) were found to be the same in both groups (Hong, Kim, Chung, Yung, & Kil, 2010). The 6th article reviewed discusses a study designed to compare the efficacy of IV paracetamol and IV lornoxicam to treat postoperative pain. Participants included sixty patients scheduled for lower abdominal surgery who were randomized to one of three groups. One group received IV paracetamol every six hours for postoperative pain; another group received IV lornoxicam immediately after surgery and then 12 hours later; and the third (the control group) received isotonic saline. Pain was also treated postoperatively with patient-controlled morphine. Outcome measures included pain scores, morphine consumption, and side effects. Pain scores were lower for the paracetamol and lornoxicam groups compared to the control, when at rest and when coughing. Pain scores were lower in the lornoxicam group when compared to the paracetamol group only when coughing. The lornoxicam and paracetamol groups both had less morphine consumption than the control group; however, it was significantly lower in the lornoxicam group when compared to the paracetamol group. Medication side effects were similar in all three groups (Mowafi et al., 2012). I strongly believe that this study should have consulted the anaesthesiologists who highly focus on surgical patients and pain relief. The 7th article by Irena Melnikowa titled “Pain Market” (2010) talks about the prevalence of pain in the United Stated with the statictics showing tha about 35.5 % which translates to 105 million people. Its purpose is to highlight the pain market and drugs commonly used in treating orthopedic postoperative pain magnagement. The research question asks whtich durg has a major share in the pain market. The author reviewed the pain the most used durg for pain management. Melnikowa points at the fact he prevailling pain management strategies relied on drugs known to have analgesic properties. The author recommentds that Ofirmev which is an intravenous drug to be the best for postoperative pain managemnet. Though not fully approved yet, the author expressed surely of the fact that is was to replace the current drugs used in magaging post operative pains. The results show that Ofirmev use is still low because it has not yet been fully in the market; however, it was more efficient than others. It is also recommended for both acute pain which are associated to injury or postoperative and chronic pain. The research methods were quantitative where data was collected on different pains individuals go through. The article relates to orthopedic postoperative pain management with Ofirmev the newest drug in the market because of its efficiency (Melnikova, 2010). The gap that I observed in this study is that ofirmev is a new drug; it needs further research studies. An article by Powell, Davies, Bannister and Macrae (2009) tilted “Challenge of Improving Postoperative Pain Mangement: Case Studies of Three Acute Pain Services in the UK National Health Service” talks about pain management improvement using drugs. The purpose of the article is to highlight how to manage orhtopedic postoperative pain. The research question is what are the challenges for improving postoperative pain management in patients who often experience excruciating pain. The method incorporated three case studies through semi-structured interviews and documentary interview. Spesciffically, 71 interview and documentary reviews were conducted and they embraced nurses, surgeons, anesthetic, health managers and professionals. The details did differ by some extent but the bottom line is that they addressed the challenge effectively. They acknowledge the fact that the prevailing drugs do ot offer the desired results and are only used because of their availability rather reliability. Postoperative pain management is imperative among health care professionals because it has become an Achilles tendon in health care services, especially after services. The article relates to orthopedic post operative pain management because it highlights the need for improved pain management which is through Ofirmev (Powel et al, 2009). Alfieri, Amid, Campanelli, Izard, Kehlet, Wijsmuller, Miceli and Doglietto (2010) in their article examine the guidelines for prevention and management of potoperative chronic pain, expecially after hernia surgery. The purpose of ther article is to provide similar definition and terminology of chronic pain of the groin after hemiorrhaphy. It also provides guidelines on how to prevent and treat chronic pain. The research question was when to consider surgical treatment versus treatment of medical pain management. The method used included a hernia surgery group of nine experts who gave out six clinical questions which they answered. The results show that chronic groin pain definition was reconciled. The article realated to post operative pain management because Ofimev is a drug for managing pain after an operation. Ofirmev is more prefereed to surgical pain treatment. However, more research still needs to done the best post operative orthopedic pain management because of the continued progress research and the need for a better drug than Ofirmev (Alfrei et at, 2011). Jones and Merill (2012) wrote an article about IV acetaminophen for the management of pain in orthopedic patients. The purpose of their research was to explore the best piece of evidence with regard to efficacy and safety of IV acetaminophen in orthtopedic postoperative pain management. The research question posed was whether or not there were safety concerns related to the use of IV acetaminophen for treating pain after orthopedic surgical operation as manifested by adverse events that are related to drug. The second question was what IV acetaminophen efficacy is for treating pain after having an orthopedic surgery as proved by the requirement for rescue medication and pain relief. The research methodology included use of selected quantitative papers assessed by two freelance reviewers to enhance methodological validity. The quatitative data was produced from papers using a standarlized tool for extracting data. Results show that there was considerable pain relief using Intravenous Acetaminophen. The article correlates to the topic post operative pain management in orthopedic patients and involved the use of Ofirmev which provides better management of pain in patients experiencing moderate or servere pain. Though there are consistencies with other studies concerning post operative pain management in orthopedic patients, there is need for more studues on Intravenous acetaminophen because of the fact that orthopedic patients often experience severe pain (Jones & Merill, 2012). In a study that assessed the efficacy of IV paracetamol as adjuvant to IV meperidine for the post-surgical procedures in an ICU, one group of 20 patients was given saline IV at 100 mL per 6 hours + IV meperidine, while the other group of 20 was given 1 gm of IV paracetamol per 6 hours + IV meperidine. Duration for both treatments was 24 hours. The group that used IV paracetamol recovered 3 hours earlier, consumed less meperidine and experienced less sedation.(Memis et al, 2010) For outpatients, Intravenous Acetaminophen could not be recommended, according to Api et al (2009). To evaluate efficacy of Intravenous Paracetamol to relieve pain during implementation of fractional curettage technique, two treatment groups were evaluated. Mild to moderate pain would be experienced by the patient. For fractional curettage procedures, the administration of IV paracetamol made little difference and therefore could not be recommended for postoperative analgesia of outpatients. Uysal et al (2011) conducted a study comparing the effect of Tramadol versus the effect of I.V. Acetaminophen. Tramadol is a milder version effect of opioids on the Central Nervous System. Sometimes used for postoperative analgesia, Tramadol is, however, known for its usual side effect which is Postoperative Nausea and Vomiting (PONV). Paracetamol does not have such a side effect if given at the right dosage. Thus, when compared with I.V. Paracetamol, in the clinical study involving 64 post operative children, those treated with I.V. Paracetamol were able to recover faster than those treated with Tramadol. Getting the mean or average time of recovery, those who were treated with I.V. Paracetamol recovered in “10.6 +/- 17.8 min. vs. 18.1 +/- 22.6 min. in the Tramadol Group” (p.56). There was insignificant difference in the efficacy. However, there were apparent advantages with using I.V. paracetamol for postoperative children who underwent surgery for adenotonsillectomy. Research Questions The hypothesis of this paper is that I.V. Acetaminophen, also known as Intravenous Paracetamol, has proven to be effective and safe in reducing the severity of pain and in preventing postoperative pain from becoming excruciating. It would be interesting to know how many patients and which group of patients responded well to the Intravenous Acetaminophen. Out of the sample sizes in clinical trials, can there be any certainty of a percentage of patients who would benefit from the use of Ofirmev? How did the doctors intervene to prevent moderate to severe patient of postoperative patients? In the literature review, the doctors who conducted the clinical trials aimed to prevent pain from becoming severe after operation about 4 to 6 hours from the time anaesthesia was administered. Each clinical trial at least tried treatment using Intravenous Paracetamol for one group while another group was given opioids. There were clinical trials wherein a third group simply received placebo and rescue medications for those who finally felt the severe pain. Was there a clear quantitative way of measuring the severity of pain? Or how did the doctors say some experienced mild pain? Others experienced moderate pain, and still there were those who experienced severe pain? Doctors normally allow the patients to rate the pain they felt. A score of 1 or 0 meant no pain. In contrast, a score of 10 meant the most excruciating pain. Thus, at the time when the anaesthesia no longer had an effect and the I.V. Acetaminophen was not yet fully absorbed, the patient felt great pain. After full absorption of the analgesics, they may be asked to rate the pain they felt and most likely, they would score it to be less than 10. What has been discovered so far is that patients felt 50% less severity of pain with the use of I.V. Acetaminophen. Consistency in Research Results indicate that Ofirmev is the drug of choice for postperative pain management because this is the only US FDA approved I.V. Paracetamol. This is also because its administration is easier and the side effect are minimal compared to opioids. Surgeons furthermore observed the drug does not cause bleeding. While other drugs delay the process of recovery, Ofirmev go hand in hand with quick recorvery and pain management (Dunn et al, 2012). Trial results confirmed that indeed Ofirmev is a good drug for managing pain in patients who have undergone surgical operation. Statistics show that the drug has grown to become a leader globaly in the injectable analgesics market. It is estimated that the sales of Ofirmev could well hit between $800 and $900 million annually in sales. The studies have as well verified that Ofirmev when used as directed by the physicians, provides the better pain management solutions to patients and doctors who have until now been worried about the available pain relieving drug (Daily Med, 2010). Methodology A. Population Many clinical trials related to the use of Intravenous Acetaminophen were reviewed. Based on the available resources, most of those clinical trials involved postoperative patients from a mixture of different types of surgery. The common denominator was the experience of moderate to severe pain. However, there were several relevant clinical studies that consisted of specific patients, for example, (a)made up of all children, (b)made up of all elderly ages 65 years and above, and (c)made up of all adults. One compilation of clinical trials up to May 2010, which was more than a year before Ofirmev was patented, was said to involve 3,896 patients. Of that number, over 2,100 received I.V. paracetamol while the others received placebo and/or rescue medications. More than 12 other clinical trials were reviewed on top of that compilation. Only one did not have any significant finding. B. Sampling Strategy Because most of the patients studied were postoperative, the sample population was made up of patients who were about to experience severe pain after the anaesthesia effects were expected to lapse. As a matter of fact, there were those who needed rescue medication with opioids like morphine, because the analgesic was not enough for them to experience some comfort (Candiotti et al 2010). In other words, the patients were about to feel the worst pain following the end of anaesthesia effect. C. How Data Were Collected Different clinical studies explain how patients were set up. Some would receive merely Saline Solution. Others were given I.V. paracetamol injected into the liquids supplying the patients through their veins. There were those who received a mixture of i.v. propacetamol + i.v. paracetamol via the liquids connected to the patients. And there were others who had to receive rescue medication depending on the doctor’s prescription for the specific patient. For this study, there is only a compilation of those clinical trials that collected data in different ways. Only clinical studies from recognized medical journals prepared by doctors were included. Statements of other doctors, who were not directly involved in the clinical studies actually performed, .were only utilized as guide to find more studies that could substantiate their statements. Thus, the actual results of clinical studies are the sources of data. They came from the official documentation of doctors who reported the results of clinical studies involving mostly postoperative patients. D. Potential Data Analysis Methods This study relies on the data analysis of doctors when they conducted the clinical trials. There were similarities in the way they measured pain. And each clinical trial described the respective methods. Since there are many of those clinical trials, the focus of this paper was to simply gather the conclusions and whatever significantly different method were used (if any) in order to trace any reason why there was a difference in their findings. But the findings discovered were consistently positive. Therefore, regardless of how the data was analyzed, the same efficacy and safety and favourable conclusions were arrived at. E. Moral and Ethical Issues For the purpose of this documentation, there was no moral or ethical issue involved. Those who performed the clinical trials went through their standard operating procedures of preparing for surgical procedures, whereas the gathering of data based on their uploaded reports did not violate anybody’s privacy. No patient identification is disclosed in this study. Only the authors of the clinical trials were identified along with the titles of their respective studies Conclusion The introduction of Ofirmev sometime mid-2011 has resulted in many clinical studies, mostly postoperative patients treated with Intravenous Acetaminophen to lessen the use of opioids. Findings have so far been favorable in the sense that it did reduce the amount of opioids given and allowed patients to recover faster. There were no opioid-like side effects as a result of using Intravenous Paracetamol. Yet, its efficacy in providing pain relief was established by McMicol et al (2011) after researching multiple clinical trials involving 3,896 patients and 36 researched studies. Other clinical studies referred to in this paper confirmed the efficacy and safety. There was no report that said patients did not benefit from the I.V. Acetaminophen. But almost all studies cited the disadvantages of depending on opioids. Ofirmev has no competitor at this time because of two patents protecting the corresponding IPR. One gap observed was the limitation of each clinical study with regards to the type of postoperative patients who benefited the most. This could not be exactly identified, although what has been referred to in this study was a combination of different patients with different surgical conditions. It seemed that in general, postoperative patients benefited regardless of the kind of surgery they had to undergo. Definitely some needed rescue medication which means pain was severe and purely I.V. Acetaminophen could not yet take over the recovery stage. As a matter of fact, the clinical studies researched by McMicol reported only 50% pain relief. And so the other gap pertains to the question of efficacy to what percentage of postoperative patients, given qualified participant? Yudt (2012, p.17) mentioned Ofirmev’s efficacy for “Orthopedic Surgery, Dental Surgery, Laparoscopic Abdominal Surgery, Endoscopic Surgery, Gynecologic Surgery, Cardiac Surgery, and Neurosurgery”. But verifying these will require an organization of clinical studies corresponding to each of type of surgery. What this paper has established aside from efficacy and safety are the prescribed limitations to make Ofirmev safe and potent. For postoperative pain relief, the maximum dosage recommended by the FDA and practiced by doctors has been 4 grams per day for adults. For children, the dosage maximum is far less. A child weighing 33 kg. or less should be given only 50 mL I.V. Acetaminophen per dosage. The effect takes place within 15 minutes of infusion. Ofirmev was found to be safe and potent for most qualified (no contraindications) children, adults, and even elderly adults 65 years old and over provided that FDA recommended dosages are followed. More organization and gathering of data will be needed to be able to say that all postoperative requirements for pain relief can be served regardless of which type of surgery is performed for patients. At best, rescue medication should always be ready because the pain relief gained was at 50% only, with no data as of now to prove what percentage of patients will realize such a benefit. 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Journal of Pediatric Pharmacology and Therapeutics. October 2011. 16 (4): 246-261. Read More