Quantitative Research Review: Sucrose for Pain Management in Infants

This assignment provides a comprehensive review of a quantitative research article investigating the efficacy of sucrose solutions in reducing pain and distress in infants aged 16-19 months during immunization. The review covers the background of the study, including the health issue of immunization pain, previous research findings, and the study's significance. It delves into the research design, a randomized, placebo-controlled trial, and its appropriateness for the study's aim of evaluating sucrose's impact on crying time and CHEOPS pain scores. The sampling methodology, participant characteristics, and the importance of inclusion/exclusion criteria are discussed, although the original study lacked explicit inclusion/exclusion criteria. The data collection methods, primarily manual counting of crying time and CHEOPS scale assessment, are analyzed for their advantages and disadvantages. Finally, the review examines the data analysis techniques, including ANOVA and chi-square tests, and assesses the rigor and generalizability of the study's results, concluding that the findings align with existing research and can be applied in similar clinical settings.

Bachelor of Nursing
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Background of the study:
a. What is the health issue that provides the focus of this study?
In this intervention, pain as a result of needle prick at the time of immunization is mentioned.
Pain during immunization is common in neonates and new-borns.
b. Generally, what have been the results of previous studies of this issue?
Allen et al., (1996) showed that 12 % sucrose solution can produce analgesic effect.
However, this effect was not statistically significant. Ramenghi et al., (1996) showed that
infants exhibited reduced crying time in comparison with the placebo group when
administered with sucrose solution. Reis et al., (2003) showed that sucrose didn’t exhibit
positive effect on the crying time in infants.
c. 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.
Overview of the research:
a. 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 should be mentioned separately; however, in this research article aim was mentioned in
the introduction section.
b. What research design was used?
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Randomized, placebo-controlled study design was used in this quantitative intervention.
c. Describe the main characteristics of the research design identified.
In randomised controlled trial study design, participants are being assigned to separate groups
and every group being assigned with specific intervention or treatment. Non-medicated
intervention being given to the placebo group. People participated in the RCTs are called as
subject. In this intervention, subjects enrolled were between age 16 – 19 months old. In RCTs
effects can be measured; hence these are called as quantitative intervention and these
measured effects should be compared with the standard intervention and placebo. RCTs are
simple and validated tool for conducting clinical research. In RCTs characteristics of
experiments include
quantitative, comparative and controlled experiments (Cook et al., 2015; Connolly et al.,
2017).
d. How did the research design chosen meet the aim(s) of the study?
Aim of this intervention is to evaluate efficacy of sucrose solution on crying time in infants.
Crying time can be considered as the pain sensation in infants. Pain sensation in infants can
be evaluated by counting crying time in comparison with the placebo after administration
with the sucrose solution. In RCTs quantitation and comparison need to be carried out; hence
RCT design meet aim of this study.
Sampling :
a. What were the characteristics of participants in this study?
Subjects in this study were infants in the age group between 16 – 19 months. Characteristics
of these infants include born at term, with normal birth weight, healthy and were with routine
well-child care.
b. What are the inclusion and exclusion criteria of the sample?
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Inclusion and exclusion criteria should be integral part of RCTs; hence these were not
mentioned in this study.
c. Why is it important to have these criteria identified before recruitment starts?
Sample universe can be defined through inclusion and exclusion criteria. Inclusion and
exclusion can also be beneficial in subject selection and identification of the patient. Present
health status of the subjects can be determined using inclusion and exclusion criteria.
Variability among recruited participants can be reduced by incorporating inclusion and
exclusion criteria. Even though, these are advantages of incorporating inclusion and
exclusion criteria, these were not mentioned in this study (Ronconi et al., 2014).
d. What sampling technique was used in this study?
In this intervention, random sampling technique was implemented in which each participant
can have equivalent chance for being recruited in the study. This is a type of probability
sampling method and in this sampling method each participant has chance being recruited in
the study. This is a simple sampling method of single step and each participant has chance of
being selected independently (Glennerster and Takavarasha, 2013). Each participant
represents specific population. In this RCT, 537 participants were recruited and allocated to
different 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.
e. How was this sample appropriate for meeting the research aim?
In quantitative randomised controlled research, subjects should be assigned to different
groups and particular intervention should be provided for every group. Aim of this study was
to assess effect of sucrose on pain in infant’s post immunization and its comparison to the
placebo group. In this study, subjects in age group 16 – 19 months were recruited and
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assigned to intervention group and placebo group. Hence, this sample is appropriate to meet
aim of the research (Elizabeth and Jonathan, 2013).
Data collection :
a. How were the data collected?
Quantitative data was collected in terms of counting of crying time. Paediatrician counted
crying time from time of insertion of needle and cessation of crying during immunization. An
objective scale CHEOPS was used for determining behavioural and pain response. CHEOPS
scale includes six different types of pain behaviour like cry, facial expression, verbal, torso,
touch, and legs. Written form was used for recording pain behaviour and pain behaviour was
recorded by the same paediatrician who counted crying time. Minimum level of pain was set
at 4 points on pain scale and maximum pain score observed was at 13 points. Parameters
determined in this study like crying time and CHEOPS pain score were subjective
parameters. Hence, principal investigator need to be blinded while determining these
parameters. In this study principal investigator was considered as blinded because while
administering sucrose principal investigator was not available. Accurate data can be collected
by designing research question prior to initiation of the study. In this quantitative study also,
research question was designed prior to initiation of the study. Tabular representation was
used for collected numerical and statistical data (Elizabeth and Jonathan, 2013).
What specifically researcher do?
Paediatrician observed and counted crying time for every subject. Manual method was
implemented for counting crying time. Time period between initiation of injection and
cessation of crying was considered as the crying time. Manual crying time counting is a
robust method; however, there is potential biasness in this method of data collection.
Paediatrician used CHEOPS forms for collecting data for behavioural pain response. Crying
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time counting and behavioural pain response determination was performed by the same
paediatrician.
How did this data collection method fit the aims of the study:
There should be robust correlation between the aim of the study and implemented method of
data collection. Aim of this study was to evaluate effect of sucrose solution on the crying
time in infants during immunization and in this study manual method for counting crying
time was implemented. Hence, data collection method fits the aim of the study.
d. What might have been some advantages and disadvantages of this method of data
collection?
Advantages:
Manual method of data collection was implemented in this study. This manual method of
data collection can save cost of the project significantly, as there is no requirement of costlier
instrument or technology for data collection.
Manual method of data collection is with high accuracy because crying time can not be
counted by instruments accurately.
Disadvantages:
Manual method of data collection is a labour-intensive method. Hence, more number of
subjects can not be recruited in this method of data collection. Recruitment of more number
of subjects can lead recruitment of more number of researchers because manual crying time
counting is not practically feasible by single researcher. Moreover, more number of
researchers can produce variability in the data collection (Mellinger and Hanson, 2016)
e. From your understanding of the weekly readings, what if any, are some alternative
methods of data collection that these researchers could have chosen?
It is not required to use alternative method of data collection because used method is
appropriate method of data collection.
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Data analysis and results:
How were data analysed?
Statistical analysis was performed by using SPSS 16.0 for Windows (Chicago, IL, USA).
Analysis of variance (ANOVA) test and chi-square test were used for statistical analysis.
Variability between means of more than two groups can be analysed by using ANOVA and
comparison between rates of more than two groups can be analysed using chi-square test.
Independent factors influencing dependent two-categorical variables can be determined by
using binary logistics regression. p<0.05 was considered as statistical significance.
Regression analysis was performed by Forward-likelihood ratio method. In this method,
significance of the score statistic illustrate entry testing and probability of a likelihood-ratio
statistic illustrate removal testing (Faltin et al., 2012).
b. Was the data analysis method appropriate for the study question and the research
design?
Statistical analysis using ANOVA is the suitable for data analysis because it is most widely
implemented and accepted method for evaluating difference among and between groups.
Variable and multiple research questions can be effectively addressed using ANOVA. In this
intervention, mean difference among groups like intervention and placebo group need to be
identified. In this intervention, 75 % and 25 % sucrose solutions were the intervention groups
and sterile water was the placebo group. In chi-square test, probability of observations in
relation to the null hypothesis can be made. Rate difference between two or more groups can
be determined in chi-square test. In this study, chi-square test was used to find difference in
rate of crying among 75 % sucrose solution, 25 % sucrose solution and sterile water. Pain
score 4 was set as dependent variable. Independent variable can change dependent variable.
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This influence of independent variable on the dependent variable can be evaluated by binary
logistic regression (Faltin et al., 2012).
c. What did the researchers say about the rigour of their analysis?
In quantitative research methodology, validity and reliability can determine rigour. Outcome
of this study demonstrated that analgesic effect in neonates is due to concentrated sucrose
solution. This outcome is in agreement with other studies; hence these results are valid and
reliable (Roth, 2015).
d. How did the researchers describe the significance of the results?
In most of the sucrose interventions, only crying time was counted and determination of
CHEOPS pain scores was not evident. Hence, this study is beneficial in determining other
dimensions like behavioural pain-response. In previous studies, sucrose as analgesic was
determined in new-borns; however, in this study it was determined on infants of 16 – 19
months old
e. Into which other settings can these results be generalised?
Outcome of this study can be used in other ambulatory practice sites and hospital settings
with same age group patients.
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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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