Effect of Sucrose Solution on Pain Due to Immunization in Infants: A Randomized Controlled Trial

This study evaluates the efficacy of sucrose solution on reducing pain during immunization in infants. The study used a randomized, placebo-controlled design and collected data on crying time and pain scores using the CHEOPS scale. The results showed that sucrose solution can reduce pain during immunization in infants. The study recruited infants between the ages of 16-19 months who were born at term, were of normal birth weight, were healthy, and were under routine well-child care. The study used manual data collection methods and employed statistical analysis using ANOVA, chi-square test, and binary regression analysis. The results of the study can be generalized to other ambulatory practice sites and hospital settings in the same age group participants.

Research for Nursing and Midwifery
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Background of the study:
a. 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.
b. 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.
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 could have been mentioned separately; however, it was mentioned in the introduction
part of the research article.
b. What research design was used?
In this study, randomized, placebo-controlled study design was employed.
c. 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
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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).
d. 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.
Sampling :
a. 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
were born at term, were of normal birth weight, were healthy, and were under routine well-
child care.
b. What are the inclusion and exclusion criteria of the sample?
In this study, inclusion and exclusion criteria are not mentioned.
c. 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).
d. 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 %
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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 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).
Data collection :
a. 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).
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.
How did this data collection method fit the aims of the study :
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
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infants after immunization which indicates pain in the infants. Data was collected manually
related to crying time in infants after immunization.
d. What might have been some advantages and disadvantages of this method of data
collection?
Advantages:
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.
Disadvantages :
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)
e. 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.
Data analysis and results:
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).
b. Was the data analysis method appropriate for the study question and the research
design?
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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).
c. 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).
d. 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.
e. 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.
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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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