Randomized Controlled Trial (RCT)
Dsicuss about the Reduction Of Pain Response In Premature Infants.
- What is the health issue that provides the focus of this study?
In this study, pain due to needle prick during immunization is being discussed. Pain due to immunization in neonates and new-borns is very common issue.
- Generally, what have been the results of previous studies of this issue?
Allen et al., (1996) demonstrated that 12 % sucrose solution exhibited analgesic effect, however there was no statistically significant effect. Ramenghi et al., (1996) demonstrated that infants treated with sucrose solution showed less crying time in comparison to the placebo group. Reis et al., (2003) didn’t demonstrated effect of sucrose solution on the crying time in infants.
- What is the significance of the study?
Sucrose solution has proven analgesic activity. In this study, sucrose was evaluated for reducing pain during immunization in infants. In this study, effect of sucrose on pain due to immunization was studied in infants of 16–19-month-old infants.
- What was the aim of the research?
The aim of our study was to determine whether using 2mL of a 75 % sucrose or a 25 % sucrose solution decreases the infant crying time and Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) scores after immunization with intramuscular diphtheria, tetanus, and acellular pertussis(DTaP)/H influenza type b/inactive polio vaccination (IPV) (along with oral polio vaccination(OPV)), pneumococcus and hepatitis A in 16–19-month old infants. Aim could have been mentioned separately; however, it was mentioned in the introduction part of the research article.
- What research design was used?
In this study, randomized, placebo-controlled study design was employed.
- Describe the main characteristics of the research design identified.
In randomised controlled trials, different groups are being assigned randomly to different groups and each group being given specific intervention or treatment. Placebo group would be administered with non-pharmacological intervention. People being recruited in the RCTs are called as participants or subject. In this study, 16 – 19 months infants were being considered as subjects. RCTs are being considered as quantitative because in RCTs effects are being measured and compared to the standard intervention and placebo. RCTs are being considered as simple, widely accepted and powerful tool in the clinical research. Experiments being conducted in RCTs are quantitative, comparative and controlled experiments (Cook et al., 2015; Connolly et al., 2017).
- How did the research design chosen meet the aim(s) of the study?
Aim of this study is to assesses efficacy of sucrose solution on crying time in infants which reflects pain sensation in infants. This pain sensation can be assessed by administering sucrose solution, counting crying time and comparing it with placebo. In RCTs all these aspects need to be completed, hence RCT can be helpful in achieving aim of the study.
- What were the characteristics of participants in this study?
In this study, infants between age group 16 – 19 months are being recruited. These infants were
Participant Selection and Sampling Technique
were born at term, were of normal birth weight, were healthy, and were under routine well-child care.
- What are the inclusion and exclusion criteria of the sample?
In this study, inclusion and exclusion criteria are not mentioned.
- Why is it important to have these criteria identified before recruitment starts?
Inclusion and exclusion criteria can be helpful in defining sample universe. Subject selection can be made through inclusion and exclusion criteria and identification of patient characteristics is feasible through inclusion and exclusion criteria. Inclusion and exclusion criteria can also be helpful in understanding of current health status of the participants. In a study, there should not be variability among participants. This variability can be reduced by considering inclusion and exclusion criteria in the study. However, in this study, inclusion and exclusion criteria for the participants was not mentioned (Ronconi et al., 2014).
- What sampling technique was used in this study?
Random sampling technique was implemented in this study. In random sampling method each participant can get equal opportunity for participation in the study. It comes under probability sampling method and in probability sapling method there is probability of each participant being selected for participation in the study. Random sampling is a simple sampling which can be completed in single step and every member can be selected independently (Glennerster and Takavarasha, 2013). Each participant is the representative of that particular population. In this quantitative study, 537 participants were being allocated to varied groups like (1) an experimental (75 % sucrose solution), (2) an experimental (25 % sucrose solution), or (3) a control (sterile water solution) group according to the closed envelope technique.
- How was this sample appropriate for meeting the research aim?
In quantitative research, participants need to be sampled to different groups and specific intervention need to be provided for each group. Aim of this study is evaluate effect of sucrose solution on analgesic effect after immunization in infants. In this study, participants in the age group of 16 – 19 months are recruited (Elizabeth and Jonathan, 2013).
- How were the data collected?
Paediatrician collected information related crying time by counting time between insertion of needle and cessation of crying. Behavioural response and pain response was recorded by using an objective scale CHEOPS. CHEOPS scale comprised of six types of pain behaviour like cry, facial expression, verbal, torso, touch, and legs. These pain behaviours were recorded on the written form and this form was completed by same paediatrician who counted crying time. Lower pain scale for pain was set at 4 and maximum score for pain was observed at 13. Since, crying time and CHEOPS pain score are subjective parameters, principal investigator need to be blinded. Principal investigator was not available while providing intervention to the participants. For collection of the accurate data, research question need to be properly defined prior to start of the study. In this study also, research question was designed and defined before executing study. Collected data was presented in numerical and statistical form in tabular form. There is possibility that un-anticipated data can also be collected along with anticipated data. However, un-anticipated data was not collected in this study (Elizabeth and Jonathan, 2013).
Data Collection and Analysis
What specifically researcher do?
Paediatrician observed and counted crying time for each participant. Paediatrician counted crying time manually. Crying time was counted between the initiation of the injection and cessation of crying. This manual counting method can be considered as robust method for data collection and there is also chances of biasness in data collection. CHEOPS forms were used for collecting information related to behavioural pain response. Same paediatrician was involved in collecting data for counting crying time and behavioural pain response.
In this study, robust correlation was established between aim of the study and method of data collection. Aim was set to collect data related to effect of sucrose solution on carrying time of infants after immunization which indicates pain in the infants. Data was collected manually related to crying time in infants after immunization.
- What might have been some advantages and disadvantages of this method of data collection?
Manual data collection can reduce cost of the study significantly because this data collection doesn’t require costlier instrument or technology.
Accuracy can be predicted more in manual data collection method because crying time can not be counted by using instrument. Hence, instrumental errors can be eliminated.
There can be limitation for the recruitment of participants in manual method of data collection. Recruitment of more number of participants impose recruitment of more number of researchers because counting carrying time for all the participants by one researcher is not practically feasible. Moreover, more number of researchers can produce variation in the collected data (Mellinger and Hanson, 2016)
- From your understanding of the weekly readings, what if any, are some alternative methods of data collection that these researchers could have chosen?
Manual method of data collection used in this study is most suited for this study and other method of data collection is not required.
How were data analysed?
SPSS 16.0 for Windows (Chicago, IL, USA) was used for the statistical analysis. Analysis of variance (ANOVA) test and chi-square test were used for statistical analysis. ANOVA was implemented for measuring difference between means of different groups like 75 % and 25 % sucrose group and placebo group. Chi-square test was used for comparison of rates among groups like 75 % and 25 % sucrose group and placebo group. Influence of independent factors on dependent two-categorical variables was estimated using the Binary logistics regression method. p<0.05 was considered as statistical significance. Regression analysis was done by using Forward-likelihood ratio method. In this method, entry testing is dependent upon significance of the score statistic and removal testing dependent upon probability of a likelihood-ratio statistic (Faltin et al., 2012).
- Was the data analysis method appropriate for the study question and the research design?
ANOVA method can be considered as the appropriate method for statistical analysis because it is most commonly used method and valid method useful for finding variation among different groups. ANOVA can be applied to diverse practical problems. In this study mean difference between the different groups like 75 % sucrose solution, 25 % sucrose solution and sterile water solution group was calculated. Chi-square test can be useful to identify probability of observations and its relation to null hypothesis. Using chi-square test, significant rate difference among 75 % sucrose solution, 25 % sucrose solution and sterile water solution groups was identified. Pain score 4 was decided as the dependent variable and it can be altered due to alteration in the independent variable. Hence, in this study, binary regression analysis was used for assessing effect of independent variables on dependent variables (Faltin et al., 2012).
- What did the researchers say about the rigour of their analysis?
Validity and reliability are the two parameters which can be used for the analysing rigour in quantitative research. Data obtained in this study is also corelating with previously conducted studies also. It indicates validity and reliability of the obtained results (Roth, 2015).
- How did the researchers describe the significance of the results?
In most of the studies, effect of sucrose solution was evaluated on crying time only. However, in this study behavioural aspects of pain were assessed using CHEOPS pain scores. Hence, physical aspect of pain like crying time along with behavioural aspects were determined in this study. As a result, different dimensions of pain due to administration of sucrose solution were evaluated in this study. This study was conducted in infants between 16- 19months old; however previous most of the studies were conducted on new-born.
- Into which other settings can these results be generalised?
Outcome of this study can be implemented in other ambulatory practice sites and hospital settings in the same age group participants.
References:
Allen, K.D., White, D.D., and Walburn, J.N. (1996). Sucrose as an analgesic agent for infants during immunization injections. Archives of Pediatrics & Adolescent Medicine, 150(3), 270–274.
Cook, J.A., Hislop, J., Altman, D.G., et al. (2015). Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers. Trials, 16:12. doi: 10.1186/s13063-014-0526-8.
Connolly, P., Andy, B., Miller, S., et al. (2017). Using Randomised Controlled Trials in Education. SAGE.
Elizabeth, C., and Jonathan, D. (2013). Quantitative Health Research: Issues And Methods: Issues and Methods. McGraw-Hill Education (UK).
Faltin, F., Ron, S. K., and Fabrizio, R. (2012). Statistical Methods in Healthcare. John Wiley & Sons.
Glennerster, R., and Kudzai, T. (2013). Running Randomized Evaluations: A Practical Guide. Princeton University Press.
Mellinger, C. D., and Hanson, T. A. (2016). Quantitative Research Methods in Translation and Interpreting Studies. Routledge.
Ramenghi, L.A., Wood, C.M., Grifith, G.C., and Lvene, M.I. (1996). Reduction of pain response in premature infants using intraoral sucrose. Archives of Disease in Childhood. Fetal and Neonatal Edition, 74, 126–128.
Ronconi, J.M., Shiner, B., and Watts, B.V. (2014). Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. Journal of Psychiatric Practice, 20(1), 25-37.
Roth, W. M. (2015). Rigorous Data Analysis: Beyond “Anything Goes”. Springer.
Reis, E.C., Roth, E.K., Syphan, J.L., Tarbell, S.E., and Holubkov, R. (2003). Effective pain reduction for multiple immunization injections in young infants. Archives of Pediatrics & Adolescent Medicine, 157(11), 1115–1120.
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