Low-Dose Ketamine For Management Of Acute Pain In Adult Patients: Thesis Sample
Pre-Hospital and Emergency Department Settings
N255B: Diagnosis and Management of Acutely Ill and Injured Patients
The first paper critiqued was “Low-dose Ketamine Improves Pain Relief in Patients Receiving Intravenous Opioids for Acute Pain in the Emergency Department: Results of a Randomized, Double-blind, and Clinical Trial,” published last year in the journal Academic Emergency Medicine. The title describes the study very well. The four researchers were represented by two medical doctors. One doctor also held a Master of Public Health degree (MPH) and a ScD (Science Doctorate), the latter is a research oriented academic degree similar to a PhD. The other doctor and another researcher hold MS degrees (Master of Science), and the fourth researcher is a student. The research took place at the Department of Emergency Medicine, Rhode Island Hospital, The Alpert Medical School of Brown University, Providence, Rhode Island.
A randomized, placebo-controlled, double-blind clinical trial for low-dose ketamine (LDK) was carried out by Beaudoin et al. (2014) to gain knowledge about acute moderate to severe pain relief with opioids. The purpose of the study was explained well. The effectiveness of low-dose ketamine was compared to standard care using only morphine for pain relief. The research questions were presented as the primary and secondary outcomes.
The research took place in the emergency room of Rhode Island Hospital patients coming from the surrounding large, urban area. The study required feedback from the patients as to the degree of pain relief. The attending doctor made the decision on whether or not opiods IV were in order. Ketamine is appropriate for research carried out in an emergency room setting, because the analgesia is appropriate for pain relief across a broad spectrum of injuries and acute problems. For example, pediatric patients who are frightened present a challenge, but ketamine can be used efficiently and safely under difficult circumstance (Aroni, Iacovidou, Dontas, Pourzitaki & Xanthos, 2009).
The theoretical framework was a pilot, randomized, double-blind and clinical trial. The pilot study was developed to evaluate ketamine versus morphine as an intravenous pain reliever. The feedback from the patients was the measurement of the degree of pain relief. Patient-perceived pain relief feedback is an accepted method in ketamine studies. The duration of the pilot study was ten months.
Various-aged patients arrive at emergency rooms randomly and for a diverse range of complaints. Therefore the respondents in the research did not consist of controlled sampling groups. Patients arrive randomly from a range of age groups and for a diverse range of complaints. The participants were chosen based on age, from 18 to 65. The members of each group were randomly chosen using a computer-generated block randomization schedule with block sizes equal to six. Sixty nine of the patients were randomized to the three treatment groups, but nine were withdrawn before the ketamine or placebo and morphine were administered. The three sample groups contained 20 people each.
The double-blind consisted of placebos administered with morphine to act as a control to the administering of ketamine with morphine.
The theoretical discussion is good and shows that the sample was indeed random. The setting and population were well-described. The study was appropriate for a pilot and included enough participants to provide a good sample. The primary and secondary objectives of the study were presented and easy to understand. The independent variable was the NRS score above or equal to five for the pain of the patients. The dependent variables were the demographics of the patients, the history of opioids use and the reason for admission to the emergency room. Other dependent variables related to the early release of participants or the movement of participants to a different department for furthering tests.
The flowchart diagramming how the participants were chosen is very helpful. The large amount of data collected was organized into a table that made the outcomes easy to understand (Aroni, 2009, p. 1198). The second table containing the effectiveness outcomes was somewhat confusing because the median of the continuous data (IQR) and the categorical data (%) were both reported in the table as in parenthesis as was number of participants in each group. Using a better way to distinguish the types of data can be helpful. The graph for figure 2 was difficult to read because the percent and the increments of time (in minutes) can only be understood in general; the graph would be easier to read if the gridlines were included in the graph.
Many scales were used in the study. Some were for measuring the pain (NRS scale) while most of them were used to analyze the data statistical. A table in the paper or appendix of the name of the scales, the use, the range of the scale and the meaning would really help.
The research questions were presented as descriptions of the primary and secondary outcomes. The paper distinguished well between the primary and secondary outcomes. The reason and purpose for choosing the primary and secondary outcomes were clearly stated and made the research easier to understand.
The threats to validity are viewed as the human factor, because validity refers to the correct measurement of the data of interest. For example, the personnel varied in the emergency room depending on the day and time of the eight hour shift when patients were evaluated. A number of trained research assistants (RA) identified the appropriateness of patients entering the emergency to be a member of the study. The number of RAs involved in the study was not mentioned. The medical evaluations for potential study participants were carried out by the emergency physician (EP) on duty. The number of EPs making assessments was not described. The number of cases in the emergency room at the time, and therefore the amount of stress on the EPs making decisions can adversely affect judgments on a patient’s condition or suitableness for the study. The steps in the study for timing the dosage and the pain relief perception are very important to this type of study. The timing reported must be trusted in order to apply validity to the study.
Reliability of the study results are not considered good, because the next time the tests are carried out the participants and other variables will be different, so reproducibility is not seen as a possibility. In this type of trial, the use of ranges to report results are best, and when ranges are used the reliability improves.
Although the study faced many challenges, the article is important for better understanding the effects on pain relief of low-dose ketamine administered intravenously. The data and information shared is an important contribution to knowledge. If the reader is proposing to carry out the same research at a different setting or location, the authors will need to be contacted to clarify some of the information in the article.
The second paper critiqued was “Intranasal Ketamine for Analgesia in the Emergency Department: A Prospective Observational Series,” published last year in the journal Academic Emergency Medicine. The title describes the study, but the ‘prospective observation series’ is puzzling and the article must be read to understand the thrust of the study. The nine researchers were represented by seven medical doctors, one student, and one PharmD. The mix of medical doctors and a pharmacy doctorate suggests that the research was well-done and the interactions in the human body of the intranasal ketamine may be explained in more detail by the PharmD. The collaborators on the research are from the department of emergency medicine, pathology, and pharmaceutical sciences at the University of British Columbia and the Lions Gate Hospital Emergency Department in North Vancouver, British Columbia.
The research was a prospective observational study to gain information about the low-dose ketamine (LDK) administered intranasally for pain relief specifically in an emergency department setting. The purpose of the study was explained well have three main objectives; to learn the “feasibility, effectiveness and adverse effect profile” for pain relief in an emergency department with intranasal ketamine (Andolfatto et al, 2013, p. 1050) Patients receive from 0.5 to 0.75mg/kg; therefore the maximum dose allowed was higher in the Beaudoin et al. (2009) study. In the Beaudoin et al. (2009) study larger doses were administered in the form of rescue analgesia if more pain relief was deemed necessary. The recruiting for participants was using a convenience sampling of people entering the ED six years and older.
The theoretical framework for the study is a prospective observational study and is suitable for describing the research if a 60 minute follow-up is considered enough of a length of time for learning the effects of the medicine administered. A classic clinical study using the prospective observational study follows the treated participants over time or compares the treated patients to a group with the same condition. The theoretical framework was fine in this case because the participants in the study were all experiencing baseline pain defined by a VAS reading of greater than 50mm. Several follow-ups were designed into the study so that analysis took place at 40 minutes, and then 50 minutes, and lastly after 60 minutes. The research is preliminary and a larger scale research study is going to be designed based on the observations gathered from this preliminary study.
The article explained the challenges for providing timely doses of analgesia in an ED so that the objective of the research was better understood by the reader; the objective being to evaluate and gain knowledge of intranasal administration of ketamine. The purpose that motivated the study are problems experienced in EDs including low numbers of providers on a shift, lack of stretcher space, and inability to carefully monitor the pain of individual patients.
The convenience method of gathering participants is sometimes described as an accidental sampling because the researchers do not control the make-up of the sampling groups. In this case the participants entering the ED are evaluated for suitability of meeting the eligibility requirements. The statistical description is a non-probability sampling. The method is very good for the research by Andolfatto et al. (2013) because it fits the need of meeting the objective very well. The duration of the research was four months. The physicians in the ED were trained beforehand by the primary research investigator; the lessons are assumed to reduce bias in the administration of the research during the study.
The research questions were framed as the desired primary and secondary outcomes. The outcomes were easy to understand and reasonable. The measurement of more than 50 mm on the VAS scale was the independent variable. The dependent variables were the demographics of the convenience sampling group and the reason for admission to the emergency room.
The data analysis was carried out with a description of the continuous data in the form of the medians and the interquartile ranges. The categorical data was presented as proportions and 95 percent confidence intervals. The only scale used for pain measurement was VAS and the values reported for VAS were analyzed with a Wicoxon signed-ranks test.
The reliability of the measurements is good because the same primary investigator taught the physicians how to carry out the trial. The validity of the results is considered good in terms of percentage ranges and medians of IQR ranges reported, but reproducibility of the same results in more tests is not expected to be high.
The study is particularly useful and adds to the knowledge because the presentation of the information is straight forward and well organized. The use of intranasal doses of ketamine is seen as a potential pain reliever with applications in ED settings after more research.
Discussion and Application
Both of the articles reviewed offered important research into administering ketamine in two different forms in order to relieve pain in ED settings. The first article explained research that was carried out with a great degree of complexity. The second article described a straight forward methodology better suited for further research. The tables were organized for easier understanding in the second article. Both articles present valid research outcomes and prove that more research will be worthwhile.