Effect of Iontophoretic Transdermal System for Postoperative Pain - Research Proposal Example

Part A - Research idea Study problem and aim The morphine Intravenous (IV) Patient-Controlled Analgesia (PCA) system is a standard of care used in many facilities for the management of postoperative pain. It requires the patient be anchored to a nurse-programmed pump via an intravenous line that is invasive and restrictive which impacts on recovery time and ease of use and care for the patient and nurse respectively (Hartrick et al. 2006). Patient deaths have resulted from IV PCA programming errors, as have prescription errors and overmedication (Vicente et al. 2003). Vicente et al. (2003) indicates IV PCA infusion involves pump, syringe and line preparation which consumes nursing staff time and resources. The aim of this study is to identify the fentanyl Iontophoretic Transdermal System (ITS) as an effective alternative for postoperative pain management in comparison to the morphine IV PCA system. Research question How effective is fentanyl ITS for postoperative pain management compared to morphine IV PCA? Significance of research This research will establish effectiveness of the fentanyl ITS compared with morphine IV PCA in post-operative pain management. Hartrick et al. (2006) suggests increased recovery time, patient dissatisfaction with ease of use, restricted mobility and complications arising from invasive IV catheter insertion when delivering the morphine IV PCA pain management system. Conducting this research will identify the potential benefits of fentanyl ITS versus morphine IV PCA for postoperative pain management through comparative safety studies, efficacy of pain control methods, ease of use and care, mobility status, and satisfaction levels from patient and nurse perspectives respectively (Hartrick et al. 2006; Pennington et al. 2008). Research approach A quantitative study approach would be appropriate when researching the effectiveness of fentanyl ITS compared to morphine IV pump delivered PCA pain management for the postoperative patient. Quantitative research has a scientific study approach utilising logic and structure (Elliott & Thompson 2007). The study design would include prospective randomised controlled group trials and comparative descriptive studies (Elliott & Thompson 2007; Viscusi et al. 2004). Characteristics would include random active controlled participants, controlled variable protocol, classification using observation and patient questionnaire evaluation, statistical data collection and analysis of objective quantitative outcome measures to compare gathered information for validation (Elliott & Schneider 2007; Hartrick et al. 2006;Viscusi et al. 2004). Part B – Literature Review Introduction: The use of Transdermal Fentanyl Patch System for post-operative pain management in the place of Intra-Venous (IV) delivered Patient-Controlled Analgesia (PCA) has been a widely researched and analyzed topic although it is yet to be analyzed form the point of view of patients and nurses. Transdermal Fentanyl Patch System has been found to be much more advantageous when compared to Intra-Venous (IV) delivered Patient-Controlled Analgesia (PCA) in many ways. This literature review will aim to establish the effectiveness of Fentanyl ITS when compared to IV Patient Controlled Analgesia through a framework that has three major concepts, namely; the efficacy of Fentanyl ITS in pain management, safety and overall patient convenience. A series of journal articles and papers will be used extensively to elaborate on the three concepts in the framework. Efficacy of Fentanyl ITS in pain management Studies conducted about the efficacy of Fentanyl ITS in pain management in comparison with IV Patient Controlled Analgesia show similar findings. Shireen Ahmad, David J. Hewitt and C. V. Damaraju (2007) conducted a study on the efficacy of Fentanyl ITS in pain control after a gynecologic surgery in comparison with morphine IV PCA. It was a randomized, prospective, open-label, multicenter, active-controlled study of patients treated with Fentanyl ITS or morphine IV PCA. Results of this study showed that a slightly higher percentage of patients who were using Fentanyl ITS reported increased success ratings on the PGA (patient global assessment) of the method of pain control during the first 24 hours after surgery. This shows that Fentanyl ITS is therapeutically equivalent to IV PCA in efficacy of pain control within the first 24 hours after a gynecologic surgery. It was also noted that discontinuation from the study because of IV infiltration problems was significantly higher in IV PCA category than in the Fentanyl ITS category. Hartrick et al. (2006) conducted a study on the use of Fentanyl ITS for pain management after an orthopedic surgery in comparison with IV PCA. It was a multicenter, randomized, active-controlled, open label study with patients who received Fentanyl ITS or IV PCA. The results of this study also show that Fentanyl ITS is an equivalent to IV morphine PCA for treating acute postoperative pain after an orthopedic surgery. The study reveals that Fentanyl ITS is a comparable method to control pain to morphine IV PCA and was well tolerated. Fentanyl ITS was also seen to be effective in controlling pain among the elderly and among patients with different BMIs. The study also adds that Fentanyl ITS may become a critical addition to the existing methods of controlling postoperative pain. While both the above studies show that Fentanyl ITS can be seen as a comparable and effective method to IV PCA in controlling acute pain arising after surgery, it is yet to be proven as a successful and a more permanent replacement for IV PCA. Safety Studies exploring the safety aspect of Fentanyl ITS in comparison to IV PCA have also shown considerable amount of correlation. An open label, randomized, multicenter, parallel group, active-controlled study by Minkowitz et al. (2007), analyses the safety aspect of Fentanyl ITS following a pelvic or abdominal surgery. Results of this study found that the most frequently occurring adverse side effects or events like nausea, vomiting, pruritus etc., were almost similar between the groups taking Fentanyl ITS and morphine IV PCA. In fact, patients who received Fentanyl ITS treatment reported significantly lower levels of pruritus when compared to those who received IV PCA treatment for post operation pain reduction. Also application –site reactions such as erythema, itching, vesicles, and edema etc., were mild to moderate in severity for patients treated with Fentanyl ITS. Incidents of clinically relevant respiratory depression were absent in patients treated with Fentanyl ITS. The study thus suggests that Fentanyl ITS is a safe method for controlling postoperative pain. Grond et al. (2007), in a prospective, multicenter, randomized, study of trial enrolled patients have analyzed in detail the safety characteristic of Fentanyl ITS. The results of this study showed that the study termination rates and side effects were similar between groups treated with Fentanyl ITS and morphine IV PVA. While no patient treated with Fentanyl ITS experienced respiratory depression, one case occurred among patients treated with IV PCA. Application-site reactions were also minimal in the Fentanyl ITS group. Other side effects like nausea, vomiting etc., occurred in similar levels in both groups. While both studies report similar findings with respect to respiratory depression, there is some variation regarding other side effects like nausea, application-site reactions etc. Overall Patient Convenience Study and analysis regarding patient convenience while treating with Fentanyl ITS and IV PCA have been widely made and similar conclusions have been made. Pennington et al. (2008), conducted a study using a validated patient ease of care (EOC) questionnaire in 2 prospective, randomized, open label, phase IIIb clinical trials. The study indicated more positive responses for Fentanyl ITS than for morphine IV PCA and that Fentanyl ITS was far superior in ease of care when compared to IV PCA. The study also proved that mobility of patient was much higher and easier with Fentanyl ITS than with morphine IV PCA. It also further reduced frustration and stress occurring in patients because of restricted mobility and thus contributed to the faster recovery of the patient. This, concluded the study, may be due to the needle-free, self-contained, compact design of the Fentanyl ITS. A study by Grond et al. (2007), suggests that Fentanyl ITS is much easier to use when compared to IV PCA. The study also suggested that movement of patients were far easier and much less restricted with the use of Fentanyl ITS. Further more the study also proposed that Fentanyl ITS might help in facilitating patient ambulation. Thus more favourable ratings for overall ease of care and convenience were given for Fentanyl ITS than for morphine IV PCA. Both the studies thus conclude that ease of care and overall patient convenience is far superior in Fentanyl ITS. Conclusion The literature review has presented two articles for each concept, in all six articles detailing all the three concepts that have been chosen. Each of these six articles give a thorough understanding of one particular aspect relating to the efficacy of Fentanyl ITS as a means to control postoperative pain. All of the articles follow an open label, randomized approach to arriving at the necessary conclusions. While all of the articles examine the efficacy and safety of Fentanyl ITS in comparison to IV PCA the safety, ease of use and care, mobility issues etc are yet to be established from the perspective of nurses and patients. My research will follow a quantitative approach in order to establish the effectiveness of Fentanyl ITS when compared to morphine IV PCA. The quantitative approach will be scientific in nature and utilize structure as well as logic. This research will recognize the potential benefits of Fentanyl ITS versus morphine IV PCA for postoperative pain management through comparative safety studies, efficacy of pain control methods, ease of use and care, mobility status etc., from patient and nurse perspectives. The study design would also encompass prospective randomised controlled group trials and comparative descriptive studies. Part C – Research Method Research Design To understand the effectiveness of Fentanyl ITS for postoperative pain management in comparison with morphine IV PCA, a quantitative research approach will be used. Dictionary of Nursing states that, “Quantitative research is research based on traditional scientific methods, which generates numerical data and usually seeks to establish causal relationships between two or more variables, using statistical methods to test the strength and significance of the relationships”. Will G. Hopkins (1998), says that in quantitative research the main aim is to determine the relationship between an independent variable and a dependent or outcome variable within a population. He further adds that, “For an accurate estimate of the relationship between variables, a descriptive study usually needs a sample of hundreds or even thousands of subjects”. The quantitative research in this study aims to establish the potential benefits of Fentanyl ITS through comparative studies of efficacy of pain relief, safety, ease of care, mobility, overall satisfaction levels etc., between Fentanyl ITS and morphine IV PCA. This study will mainly focus on the perspectives of nurses and patients. The quantitative data will provide statistics that will help organize results into the several benefits of Fentanyl ITS. Participants The participants proposed for this research will be patients of all ages who have undergone any kind of major surgery namely, hip replacement surgery, knee replacement surgery gynecologic surgery, abdominal or pelvic surgery etc. These patients will be from multiple urban hospitals and medical institutions from South East Queensland. The nurses taking care of these patients will also participate in the research, as the primary aim of this research is to establish the efficacy of Fentanyl ITS from the patients and nurses’ perspectives. Once the necessary permissions have been obtained form the medical institutions and hospitals and ethical approvals have been acquired patients and nurses for the research will be recruited by directly approaching them. The research will be conducted over a period of six to eight months. Although it is likely that not all who are approached will agree to participate, the sample size obtained over six to eight months will be sufficient to arrive at the results. Research Setting The research is to be conducted in private hospitals, which deal with individual specialized departments as well as multiple departments like gynecology, orthopedics, pediatrics, neurology, cardiology etc., in the urban areas of South East Queensland. By conducting research with participants from across different hospitals and across different departments ensures that a clearer result may be gained on the efficacy of Fentanyl ITS. Data Collection Data for the research will be collected in the form of a structured interview by utilizing a well developed questionnaire which has both open ended as well as close ended questions. Open-ended questions are used to gain narrative from the participant (Whitehead & Annells 2007). Open-ended questions usually ask for additional information from the participant. Since open-ended questions are perceived as less threatening, it develops trust and a good therapeutic relationship is established with the participant. Close-ended questions can be answered finitely with a yes or a no. Close-ended questions are usually quick and less time consuming and require simple answers. Both the above type of questions will be used for specific areas. The interview will take place only when a full informed consent is obtained from the participants. The quantitative data thus collected will yield the results necessary. Data Analysis The quantitative data thus collected will be systematically analyzed through a statistical analysis. For this purpose a statistical computer package will be utilized. Once the statistical analysis is over, the results will be fed into a statistical computer package. This procedure will reveal the results of the comparative study on efficacy, safety, mobility etc. Ethical Considerations Risks While gaining information on the efficacy of Fentanyl ITS in pain control after surgery, the risks to participants involved must be taken into consideration. The ethical principle of benevolence involves doing good, as well as preventing and getting rid of potential harms. In this research, risks to participants may involve psychological distress, physical inconvenience or pain and invasion of privacy. Participants may face psychological distress or physical distress while answering questions. Some may also view this as an invasion of privacy. As far as nurses are concerned the risks involved may be an invasion on their time and work. To reduce the potential risks that may arise, the participants will be assured that their welfare will be protected. The research will be conducted in secure rooms, giving them all details required and encouraging them to ask questions, thus obtaining their informed consent. They will also be assured that this will not impact their treatment or recovery in any way. Nurses will be approached and asked to participate at their own convenient time. Communication All participants have the right to make informed decisions about participating in this study. This implies full disclosure. The researcher will give all details of the research regarding the nature of study, risks and benefits involved, right of participant to withdraw or choose not to participate etc., so that the participant can make the right decision. The participants will be provided with an information sheet as well as personal interaction with researchers to enable them to make an informed decision. Informed Consent Informed consent is when the participant decides to participate in the research study after being thoroughly informed about the project and its benefits and potential outcomes. To ensure that the participant has given informed consent a plain language statement will be prepared and completed. Withdrawal Participants are entitled to withdraw from the research at any time. They will be duly informed of this and will be assured that withdrawing from their study will not impact or affect their treatment and recovery in any way. Confidentiality Participants will be assured of confidentiality at all times. Confidentiality means that any information that the participant divulges will not be made public or available to others (Wilson 1987). Each questionnaire will be coded and once it has been filled out details about the participant will not be known. At no point during the research will the participants be identified by name or any other personal details. Only those in charge of the study will have access to the responses of participants. These responses will be fed into a computer program using a password that will be known only to the main person doing the research. Data collected will be securely locked up and be accessible only to the necessary few people. References and Bibliography Ahmad , S, Hewitt , D J, Damaraju, C V (2007). Fentanyl HCl Iontophoretic Ttransdermal System Versus Intravenous Morphine Pump After Gynecologic Surgery. Arch Gynecol Obstet. 256: 251 – 258. Annells M & Whitehead D (2007) Analysing data in qualitative research. In: Nursing & Midwifery Research: Methods and Appraisal for Evidence-Based Practice. 3rd edn. (Schneider Z, Whitehead D, Elliott D, LoBiondo-Wood G & Haber J), Elsevier - Mosby, Marrickville, Sydney. pp 138-155. Elliott, D & Schneider, Z (2007). ‘Quantitative data collection and study validity’, in Schneider, Z, Whitehead, D & Elliott, D, Nursing & midwifery research, 3rd edn, Elsevier, Australia. Elliott, D & Thompson, D 2007, ‘Common quantitative methods’, in Schneider, Z, Whitehead, D & Elliott, D, Nursing & midwifery research, 3rd edn, Elsevier, Australia. Engelman, Edgard and Salengros, J C (2008). IONSYS versus morphine PCA: Analysis of the current literature using a Bayesian approach. Acute Pain 10. p 83 – 91. Grond , S and Hall, J and Spacek, A and Hoppenbrouwers, M and Richarz, U and Bonnet, F (2007). Iontophoretic transdermal system using fentanyl compared withpatient-controlled intravenous analgesia using morphine for postoperative pain management. British Journal of Anaesthesia. Hartrick, C, Bourne, M, Gargiulo, K, Damaraju, C, Vallow, S & Hewitt, D 2006, Fentanyl Iontophoretic Transdermal System for Acute-Pain Management After Orthopedic Surgery: A Comparative Study With Morphine Intravenous Patient-Controlled Analgesia, Regional Anesthesia and Pain Medicine, vol. 31, no. 6, pp. 546-554, viewed 13 March 2009, Science Direct. . Hopkins, W G (1998). Quantiative Research Design. Sportscience. University of Otago. Viewed 31 March 2009. http://www.sportsci.org/jour/0001/wghdesign.html Minkowitz, H S, Rathmell J P, Vallow , S, Gargiulo, K, Damaraju C V, Hewitt, D J (2007). Efficacy and Safety of the Fentanyl Iontophoretic Transdermal System (ITS) and Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine for Pain Management Following Abdominal or Pelvic Surgery. Pain Medicine. Vol 8, No.8. Pennington, P, Caminiti, S, Schein, J, Hewitt, D & Nelson, W 2008, Patient’s Assessment of the Convenience of Fentanyl HCl Ionotrophoretic Transdermal System(ITS) Versus Morphine Intravenous Patient-Controlled Analgesia(IVPCA) in the Management of Postoperative Pain After Major Surgery, Pain Management Nursing, 17 December 2008, viewed 15 March 2009, Science Direct. . Vicente, K, Kada-Bekhaled, K, Hillel, G, Cassano, A & Orser, B 2003, Programming errors contribute to death from patient controlled analgesia: case report and estimate of probability. Candianan Journal of Anaesthesia , vol. 50, No. 4, pp. 328-332, viewed 16 March 2009, Canadian Anaesthesiologists Society. . Viscusi, E, Reynolds, L, Chung, F, Atkinson, L & Khanna, S 2004, Patient-Controlled Transdermal Fentanyl Hydrochloride vs Intravenous Morphine Pump for Postoperative Pain: A Randomized Controlled Trial, Journal of American Medical Association, vol. 291, no.11, pp. 1333-1341, viewed 14 March 2009, American Medical Association. . Wilson, W. J (1987) The declining significance of race: The truly disadvantaged—the inner city, the underclass, and public policy. Chicago: University of Chicago Press. Read More