Comprehensive Review: Sucrose Solutions to Reduce Infant Pain Study

This assignment provides a guided review of a quantitative research article focusing on the effectiveness of sucrose solutions in reducing procedural pain in infants aged 16-19 months during vaccinations. The review covers the background of the study, including the health issue addressed, previous research findings, and the study's significance. It examines the research design, a randomized placebo-controlled trial, and its suitability for the study's aim of determining the impact of sucrose on infant crying times and distress levels. The review also analyzes the sampling methods, participant characteristics, inclusion/exclusion criteria, and appropriateness for the research aim. Furthermore, it delves into the data collection methods, including the procedures followed by researchers, the use of the CHEOPS scale for pain assessment, and potential advantages and disadvantages of the chosen methods. Finally, the assignment assesses the data analysis techniques, the rigor of the analysis, the significance of the results, and the generalizability of the findings to other settings. The study employed statistical analysis using SPSS, ANOVA, chi-square tests, and binary logistic regressions to evaluate the effectiveness of sucrose solutions in pain reduction.

1. Background of the study (Total: 10 marks)
a. What is the health issue that provides the focus of this study?
The health issues discussed here is the need to reduce the procedural pain during
the immunization or vaccinations with intramuscular diphtheria, tetanus, and
acellular pertussis (DtaP)/Haemophilus influenza type b/IPV (alongside oral
polio vaccination, OPV), intramuscular pneumococcus as well as intramuscular
hepatitis A
b. Generally, what have been the results of previous studies of this issue?
The previous studies have well-established the analgesic effect of sucrose on
newborns but have little knowledge regarding whether sucrose solution can
effectively reduce procedural pain in infants past the newborn era.
c. What is the significance of the study?
This study is significance because it adds into the literature by solving the gap
on the effectiveness of sucrose solution in the reduction of procedural pain in
infants beyond the era of the newborn. Thus, by confirming the effectiveness of
sucrose in pain reduction and distress among the infant it will to provide safe
and clinically safe immunization even for 16-19-month-old infants. Thus it has
clinical implication because sucrose remains inexpensive and easy to administer
intervention even by non-healthcare professionals and hence can always
effectively help during the vaccinations/immunizations. This, research also
gives a significance indication that sucrose can be used in the prevention of pain
during other procedures in ambulatory practices contexts as well as in hospitals,
in this cohort.

2. Overview of the research design (Total: 10 marks)
a. What was the aim of the research?
The aim of the study was to determine effects of sucrose solutions administered
orally on infant crying times and also to measure the distress in a 16 to 19-
month old cohort. This would help know whether these solutions stood effective
in procedural pain reductions in infants past the newborn era.
b. What research design was used?
A randomized placebo- controlled trial design was explored in this study.
c. Describe the main characteristics of the research design identified
In this trial, some of the subjects are given treatment, others fake treatment
(placebo) and neither the subjects or researchers know which is which till they
end of the study and hence remain blinded. The research design was quantitative
in nature (crying time and measure distress based on scale). It involved
randomization of the subjects in either of the three groups based on closed
enveloped. The groups contained experimental (75% sucrose solution),
experimental (25% sucrose solution) and control (sterile). Data collection was
primary one. Data analysis was statistical-based using SPSS, ANOVA and chi-
square test, and binary regressions.
d. How did the research design chosen meet the aim(s) of the study?
The aim of the study was met via the chosen design because it enabled the
effective data collection and analysis of the right and large sample of infants
which was then statistically analysed, discussed and interpreted to help confirm
the effectiveness of solution in pain reduction in infants beyond newborn era
during immunization.

3. Sampling (Total: 15 marks)
a. What were the characteristics of participants in this study?
The participants of the study were infants and children who were receiving their
regular vaccinations. They were aged between sixteen and nineteen months and
they were attending the well-child unit of Department of Paediatrics. The
infants were born at term, and were of normal both weight, and hence healthy
and only required routine well-child care.
b. What are the inclusion and exclusion criteria of the sample?
The infants had to be born at term, and were of normal both weight, and hence
healthy and only required routine well-child care. They were to be between 16
and 19 old months old infants. They were only to be healthy and attend their
regular well-child unit department of paediatric. They had to be those who were
receiving their regular vaccinations.
c. Why is it important to have these criteria identified before recruitment
starts?
It was extremely important to have the criteria identified before recruitment
because it would either assist the parents to agree or not to agree on whether
their infants would be used in the experiment. Also, it was important because
the intervention could only succeed when the right sample was recruited.
d. What sampling technique was used in this study?
The randomized sampling technique was employed in this study. 16 to 19-
month-old infants were randomly assigned to 1 of 3 cohorts. These included 1
(an experimental, 75% sucrose solution); 2 (an experimental, 25% sucrose
solution) or 3 (a control, sterile water solution) cohort in accordance with closed
envelop technique.

e. How was this sample appropriate for meeting the research aim?
The sample was large enough to help meet the research aim. Moreover, the
characteristics of the subjects (sixteen to nineteen-month-old) infants were
suitable as this would help meet the intended primary outcome, “crying time”
when the intervention was done in the experimental groups.
4. Data collection (Total: 20 marks)
a. How were the data collected?
A total of 694 healthy infants and kids receiving their regular immunization
aged between sixteen and nineteen months who attended the well-child unit of
Department of Paediatrics were recruited and randomized for this study between
2013 June and 2014 June. 537, overall, infants were analysed. Data was
collected as the experiments and procedures were being done as discussed in
subsequent sub-section below.
b. What specifically did the researchers do?
Researchers got permission to carry out the study from Dr. Sami Ulus Children
and Maternity Training Hospital’s ethics committee. The researchers
approached the families through research assistants that explained the probe’s
nature and acquired informed consent. The researcher subsequently assigned
16-19-month-old infants at random to one of the 3 treatments groups in
accordance with closed envelope technique. The researchers had prepared water
and sucrose solutions before the study by use of a pharmacists. They researchers
drew solutions from coded bottles and administered through a syringe. The
researcher blinded the nurses and parents to solution used nature in the entire
study. The researchers placed the solutions in coded oral syringes using

pharmacist to guarantee parents, nurses and probers stood blind to cohort
assignment. The control and experimental cohorts were given orally 2 mL of
either sterile water or 25 percent sucrose solution or 75 percent sucrose solution
before injections. The researchers recorded gender and age of the infant.
Partaking mothers were queried about their educational and socioeconomic
levels and researchers classified them as either “no schooling, illiterate,”
“primary education,” “secondary education”, or “university education”. The
socioeconomic levels were classified based on income per month per household.
The researchers also assessed in past painful experience by querying the
mothers. Researchers seated the mothers with children in their arms and single
nurse provider utilized soothing techniques. They noted the use of an infant
pacifier/pre-treatment with paracetamol. Researchers ensured that all infants
stood awake during the procedure. The nurse administered all test orally over a
period of up to 15 seconds. The nurse then orally gave OPV. DtaP,
DPT+Hib+IPV, intramuscular pneumococcus, alongside intramuscular hepatitis
A were also administered in deltoid region of left and right arm simultaneously.
The nurse administered pneumococcus vaccination for infant who were
vaccinated at 1 year of age. All infants received either three or two injections.
The whole procedure was videotaped. The researchers defined the primary
outcome (crying time) as crying from the point of insertion of need till all
activity stopped and recorded by paediatrician. The researchers used CHEOPS
to assess the acute behavioral pain response as an objective scale (9, 23, 35).
Pain behavior was categorized into six including “cry, facial expression, verbal,
torso, touch, and legs”. Researchers complemented the CHEOPS forms using
same paediatrician. Scores beyond 4 denoted pain, with the maximum pain

being 13. The researchers blinded principal investigator was recording crying
time and pain score and ensured he was absent during intervention.
c. How did this data collection method fit the aims of the study?
The data collection fit the aims because of using the right scale to score the
pain. Also, blinding the principle investigator and ensuring his absence during
investigation ensured validity and prevented any bias. RCT ensured reduced
selection bias hence results are valid and credible.
d. What might have been some advantages and disadvantages of this method
of data collection?
The advantage is that it is videotaped and hence no biasness or alterations of
data. The disadvantage is that only one nurse was involved in all administration
and hence this might be prone to error made at one point by single person
affecting the entire process.
e. From your understanding of the weekly readings, what if any, are some
alternative methods of data collection that these researchers could have
chosen?
Data could as well be collected through manual means or they could have been
drawn from the secondary studies or documentation in the hospital.
5. Data Analysis and results (Total: 20 marks)
a. How were the data analysed?
The data were statistically analysed in this study using the SPSS 16.0 version
for the Windows (Chicago, II, USA). The ANOVA test was utilized in the
investigation of the variations between means of more than 2 cohorts. The chi-
square test was used in comparing the rates between 2 or more cohorts. The

binary logistic regressions were employed in determining independent variables
that influenced the dependent 2-categorula variables with the statistical
significance being set at p<0.05.
b. Was the data analysis method appropriate for the study question and the
research design?
The data analysis was appropriate in this study. This is because the investigators
used a primary quantitative method and hence quantitative methods of analysis
including SPSS, ANOVA, chi-square tests and Binary logistic regressions
sufficed. This can be attested by the effective results that the analysis generated.
For example, the authors were able to use these test to determine whether there
were statistical differences between the groups in respect of age, weight, sex,
past painful experience, vaccination time, of injection number, paracetamol
administration and pacifier.
c. What did the researchers say about the rigour of their analysis?
The analysis of this study is believe to be highly vigorous and enabled the
researchers to meet their intended goals. For examples, the researchers have
managed to shown that past pain experience was significant independent
variable for higher CHEOPS pain scores.
d. How did the researchers describe the significance of the results?
The significance of the results was described on the basis of the p-value or
statistical significance.
e. Into which other settings can these results be generalised?
These results can also be generalized in other ambulatory practice sites and
hospitals content to prevent pain during these procedures for the infants between
sixteen and nineteen-month-old.