Intravenous Paracetamol to manage pain Research Proposal

Intravenous Paracetamol to manage pain - Research Proposal Example Patients are bound to experience pain after the effect of anaesthesia given before surgery 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. Th is 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 reference s 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 al coholic. 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 â€Å"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. Unfor tunately, the use of opioids to