RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BENGALURU , KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1. NAME OF THE CANDIDATE AND ADDRESS
Ms. JIJIN G VARGHESE,1ST YEAR M.Sc. NURSING,THE OXFORD COLLEGE OF NURSING,NO.6/9,6/11, 1ST CROSS, BEGUR ROAD,HONGASANDRA, BENGALURU-560068.
2. NAME OF THE INSTITUTION
THE OXFORD COLLEGE OF NURSING
3. COURSE OF STUDY AND SUBJECT
MASTERS OF SCIENCE IN NURSING
CHILD HEALTH NURSING
4. DATE OF ADMISSION TO COURSE
11/07/2011
5. TITLE OF THE TOPIC
A STUDY TO ASSESS THE
EFFECTIVENESS OF STRUCTURED
TEACHING PROGRAMME REGARDING
KNOWLEDGE ON PARACETAMOL
TOXICITY IN UNDER FIVE CHILDREN
AMONG MOTHERS IN A SELECTED
COMMUNITY AREA, BENGALURU.
6. BRIEF RESUME OF THE INTENDED WORK.
INTRODUCTION
“Let us put our minds together and see what life we can make for our children”
Sitting Bull
Paracetamol is widely available and has been around since 1950s. It is widely
prescribed and cheap to buy over-the-counter, making it a common drug taken in overdose. It
is a very useful analgesic (alone or in combination) and also is an antipyretic .It is normally
found as a 500mg tablet, but it is often combined with other active ingredients in various
preparations. Paracetamol combinations manufactured in India include Combiflam, Darvocet,
Acelo Plus, Ace-Proxivon, Neofebrin, Proxivon, Tramazac-PD and Ultracet1.
It is commonly used for the relief of headaches and other minor aches and pains and is
a major ingredient in numerous cold and flu remedies. In combination with opioid analgesics,
paracetamol can also be used in the management of more severe pain such as post surgical
pain and providing palliative care in advanced cancer patients. The onset of analgesia is
approximately 11 minutes after oral administration of paracetamol, and its half-life is 1–4
hours2.
Paracetamol toxicity is caused by excessive use or over dose of paracetamol, mainly
causing liver damage. Paracetamol toxicity is one of the most common causes of poisoning
worldwide. In the United States and the United Kingdom, it is the most common cause of
acute liver failure3. Risk of toxicity is based on the dose of paracetamol ingested. The
recommended dose of paracetamol in children is 10-15mg/kg or as indicated below.
0-3 months- 40mg q 4hr X 5 doses in 24 hrs.
4-11 months- 80mg q 4hr X 5 doses in 24hrs.
1 yr- 120mg q 4hr X 5 doses in 24hrs.
2-3ys- 160mg q 4hrs X 5 doses in 24hrs.
4-5yrs-240mg q 4hrs X 5 doses in 24hrs4.
After taken orally, paracetamol is well absorbed in the stomach and small intestine and
reaches a peak plasma concentration in one hour. It is inactivated by the liver by conjugation
leading to two metabolites; glucoronide or Sulphate. It is then renally excreted through urine.
When taken in overdose the liver conjugation becomes inundated, causing paracetamol to be
metabolised by an alternative pathway. This results in a toxic metabolite, N-acetyl-p-
benzoquinoneimine (NAPQI), which is itself inactivated by glutathione, rapidly preventing
any harm. However, glutathione can be run down with minor increase in the toxin and, when
this occurs, NAPQI reacts with nucleophilic aspects of the cell, leading to necrosis. Necrosis
occurs in the liver and in the kidney tubules5.
Many children will be asymptomatic for the first 24 hours or have non- specific
abdominal symptoms such as nausea and vomiting. Hepatic necrosis begins to develop after
24 hours and can progress to acute liver failure. They may also develop encephalopathy,
oliguria, hypoglycaemia, renal failure (usually occurs around day 3) and lactic acidosis.
Assessment includes history taking, examination and investigations. History to be taken on
number of tablets, formulation and any concomitant tablets including time of over dose. In
examination, usually very little to find until the patient develops acute liver failure.
Investigations include serum paracetamol level, serum creatinine, liver function test, blood
sugar level, prothrombin time and arterial blood gas analysis6.
Treatment is aimed at removing the paracetamol from the body and replacing glutathione.
Activated charcoal can be used to decrease absorption of paracetamol if the patient presents
for treatment soon after the overdose; the antidote Acetylcysteine acts as a precursor for
glutathione, helping the body regenerate enough to prevent damage to the liver. A liver
transplant is often required if damage to the liver becomes severe. Patients treated early have
a good prognosis, whereas patients that develop major liver abnormalities typically have a
poor outcome6.
6.1 NEED FOR THE STUDY
Hospital admissions due to poisoning have steadily increased from the 1950s7. Since
the mid‐1970s there has been an increase in the number of paracetamol overdoses, such that
paracetamol has now become the substance most frequently used in deliberate self‐poisoning
in the UK8. In Oxford, UK, the proportion of overdoses with paracetamol increased from
14.3% in 1976 to 42% in 1990, and in 1993, 47.8% of all overdoses involved paracetamol or
paracetamol‐containing drugs8, 9. It has also become increasingly common in other countries
including Denmark and Australia10, 11. In Scotland, the rate of paracetamol overdose increased
almost 400% between 1981–83 and 1991–93, and was higher in more deprived areas12, 13.
A study in one of the hospitals in Western Australia between 1985 and 1990 found
that 306 admissions for paracetamol overdose. Severe liver injury (defined as an alanine
transaminase >45 IU/l, a prothrombin time >18 s and encephalopathy) occurred in 6.9%, but
all recovered with supportive therapy and no patient required a liver transplant. However, in a
study of patients admitted to a specialist liver failure unit in the UK between 1987 and 1993
with a diagnosis of acute liver failure due to paracetamol poisoning, only 30% fulfilled
clinically defined transplant criteria. Patients with poorer outcomes and those listed for
transplant tended to present later to hospital and to have taken a larger overdose8.
In a prospective trial of 80 patients admitted between 1992 and 1993, 25 had acute
liver dysfunction (as defined by an INR >1.2 with or without abnormal liver function tests)
following consumption of more than 25 tablets (12.5 g) of paracetamol. Of the 80 patients,
60% had obtained tablets from blister packs, 46% from loose preparations and 6% of the
patients had used both types9.
While some drugs have limitations imposed on their availability for small adverse
risks, paracetamol is not looked upon with the same critical concern. An example of this is
terfenadine. In 1997, its availability was changed from over-the-counter to prescription‐only,
due to the risk of cardiac arrhythmias. However, an observational historical cohort study
calculated that more cardiac arrests and ventricular arrhythmic events occurred with other
over-the-counter antihistamines compared to terfenadine. Also, there was no increase in the
risk of life‐threatening ventricular arrhythmias when terfenadine was compared to ibuprofen6.
In India, paracetamol toxicity is becoming common because of negligence and
illiteracy of patients. In developed countries, paracetamol-induced acute liver failure is an
important indication for liver transplantation. Poisoning in children is usually accidental and
therapeutic misadventure due to inappropriate dosing is well documented in infants and
preschool children. The parents in advertently administer the medication to children. The
recommended dose for oral or rectal paracetamol in symptomatic fever (temperature>
38.5°C) is 15 mg/kg every 6 h (≤60 mg/kg/day), whereas the recommendation for analgesia is
15 mg/kg every 4-6 hourly, up to a maximum of 60-90 mg/kg/day for oral dose and the rectal
dose being 20 mg/kg/dose every 6 hourly, up to a maximum of 90 mg/kg/day. A sustained
administration of supratherapeutic doses of paracetamol (>90 mg/kg/day) to a sick child
younger than 2 years for more than 1 day has been identified as a significant risk for
hepatotoxicity, whereas in acute ingestion of paracetamol a higher dose of 150 mg/kg is
associated with toxicity. In the presence of risk factors, such as underlying febrile illness,
prolonged starvation, repeated vomiting, diarrhoea, poor fluid intake for more than 24 hours,
dehydration, age less than 2 years, hepatic impairment, obesity, multiple dosing, and
combination with other antipyretic agents, such as ibuprofen, a much lower dose may suffice
to cause hepatotoxicity. In this series, all the children had more than one risk factor and 5 of 6
cases had received >90 mg/kg/day of paracetamol. Thus, inadvertent usage of even
recommended doses of multiple antipyretics during febrile illness may become hepatotoxic6.
Parents frequently give over-the-counter paracetamol (acetaminophen) during
childhood illness. Parents recognized illness among their children either intuitively or by
taking notice of specific signs or symptoms. Fever is considered a definite sign of illness,
almost congruent with the disease itself. Some parents acknowledge that low or moderate
fever reflected a battle between the body and the disease-causing organism. High or rapidly
increasing fever, however, was frequently looked upon as dangerous. Mothers preferred to
stay close to their child during illness and postpone other duties. Inexperienced parents feel
particularly anxious and helpless since they often find the severity of the illness difficult to
judge. Administration of paracetamol gives parents the feeling of mastery. The medicine is
also used to calm down the child enabling sleep and rest for the whole family. Some parents
are generally interested in information about child diseases, others are only eager to know
more about it during periods of illness, and some parents are not interested as they feel
information only caused more anxiety. Fever was often judged to cause discomfort and
danger. Thus antipyretics like paracetamol were regarded as a medicine counteracting
disease. Paracetamol constituted an important tool for parents in managing different upsets
during childhood illnesses. Information is not always wanted. Better knowledge about the
significance of fever and how to handle children during common illnesses might need to be
presented in a context familiar to parents, for instance, in relation to general information on
childcare.
A study was conducted to examine under what conditions parents find treatment with
paracetamol appropriate. With the sample of 1563(99%) parents at six public health centres
were asked to select one or more among 26 indications for paracetamol treatment and to state
the body temperature at which fever medication should be used. The indications were
independently evaluated as appropriate, uncertain or inappropriate by the staff of the public
health centres. The results stated that 79% chose a fever threshold of 39 degrees c or above as
appropriate for treatment with paracetamol. Fever, earache, influenza and head ache were
frequently chosen as appropriate indications by both parents and staff. On average, parents
from non-western countries more frequently chose indications considered by the staff as
uncertain or inappropriate and seemed to use paracetamol more frequently (odds ratio 2.35;
95% CI 1.26 - 4.40 ) and in large doses than other parents did. This study indicates that
parents from non-western countries use paracetamol for their children on wider indications,
to more of their children, and in larger doses than other parents do14.
Paracetamol is a commonly used, moderately effective analgesic and antipyretic. In
overdose it causes significant morbidity and mortality. The burden to health care services is
considerable, with a high financial cost and many hospital admissions. According to the
Medicines Control Agency Medicines Act Leaflet (MAL 82, March 1996), which gives
guidance on changing the legal classification of a medicine to the General Sale List, a
criterion for inclusion on the General Sale List is: ‘where the hazard to health, the risk of
misuse, … is small and where wider sale would be a convenience to the purchaser’ (our
italics). It is surprising that paracetamol is available on the General Sale List, as it appears to
fail this criterion for an over-the-counter medication. Present approaches to reduce toxicity
have had variable and moderate effects. Other methods of reducing this burden must be
considered. These could include parental education public awareness on the effects of
overdose, further research on drug‐antidote combination tablets and changing the legal status
of adult doses from the General Sales List to the prescription‐only medicines list, or at least
restricting it to pharmacy‐only sales.
6.2. REVIEW OF LITERATURE
Review of literature for the present study has been organized under the following
headings:-
6.2.1. Reviews related to paracetamol administration in children
6.2.2. Reviews related to paracetamol overdose in children.
6.2.3. Reviews related to knowledge of mothers in administration of paracetamol to
children.
6.2.4. Reviews related to the effectiveness of Structured Teaching Programme.
6.2.1. Reviews related to paracetamol administration in children
A randomized control trial was conducted to demonstrate the efficacy of
acetaminophen prophylaxis in preventing fever after whole cell pertussis vaccination. With
the sample of children six weeks through nine months of age were randomized 1:1 to receive
upto five doses of acetaminophen (10-15mg/kg). The results revealed that a temp = 380C was
recorded for 14% (25/176) of children randomized to acetaminophen compared with 22%
(37/176) of those randomized to placebo but that was difference was not statistically
significant [ relative risk (RR), 0.63; 95% CI, 0.40-1.01] Children randomized to
acetaminophen were less likely to be reported as being much more fussy than usual (10% vs
24%) (RR, 0.42; 95% CI, 0.25-0.70) or to have the treatment assignment unblinded (3% vs
9%) (RR, 0.31; 95% CI, 0.11-0.83) than those randomized to placebo. In age-stratified
analysis among children ≥ 24 weeks of age, there was a significantly lower risk of
temperature ≥380C in the acetaminophen group (13% vs 25%; p=0.03). The study concluded
that acetaminophen may reduce the risk of post-vaccination fever and fussiness15.
A prospective randomized study was conducted to compare the ability of parents to
calculate and demonstrate the correct paracetamol dose, interval and frequency for their child.
With the sample of 160 parents accompanying children aged between one and 13 years old to
complete a paracetamol dose calculation and administration by using one of two sources of
product information leaflets or the Parental Analgesia Slide. The results revealed that a
reduction in the absolute percentage dose error from a median of 33.3% to 0% (P > 0.001)
and an increase in the number of correct dosage intervals and frequencies (59/80 to 70/80,
P=0.046). There was no difference in the number of correctly demonstrated drug volumes
(P=0.082) despite a greater number of parents opting to use an oral syringe rather than a
dosing spoon when using the slide (24/80 to 44/80, P=0.002).The study concluded that the
Parental Analgesia Slide helped to improved parental ability to calculate paracetamol dose,
interval and frequency while preserving their ability to demonstrate an accurate drug
volume16.
An experimental study was conducted to compare the antipyretic effect of 3 different
treatment regimens in children using either Ibuprofen alone, Ibuprofen combined with
acetaminophen or Ibuprofen followed by acetaminophen over a single 6-hour observation
period. With the sample of children aged 6 to 84 months were randomized with the 3
treatment groups: a single dose of Ibuprofen at the beginning of the observation period; a
single dose of Ibuprofen plus a single dose of acetaminophen at the beginning of the
observation period or Ibuprofen followed by acetaminophen at 15mg/kg. Temperatures were
measured hourly for 6 hours using a temporal artery thermometer. Sixty febrile episodes in
46 children were assessed. The results revealed that the mean (SD) age of children was 3.4
(2.2) years and 31 (51.7%) were girls. Differences among temperature curves were
significant (P > 0.001, the combined and alternating arms had significantly better antipyretics
compared with the Ibuprofen- alone group at hours 4 to 6 (hour 4, P > 0.005; hours 5 and 6,
P > 0.001). All but one of the children in the combined and alternating groups were afebrile
at hours 4, 5 and6. In contrast, for those receiving Ibuprofen alone, 30% and 50% had
temperature > 380C at hours 4,5 and 6 respectively (hour 4,P=0.002; hours 5 and 6, P <
0.001). The study concluded that during a single 6 hour observation period for these
participating children, combined and alternating doses of Ibuprofen and acetaminophen
provided greater antipyretics than Ibuprofen alone at 4 to 6 hours17.
A randomized double blind placebo controlled trial study was conducted to
investigate whether paracetamol administration (i) increases the overall duration of fever and
(ii) is effective and safe in symptomatic treatment of febrile children. With the sample of 210
febrile children (6 months-6 years) with uncomplicated respiratory tract infection received
oral paracetamol (15mg/kg) or placebo, if axillary temperature was 37.6c. Outcome measures
included fever clearance time, rate of fall of temperature, present reduction of temperature,
proportion of afebrile children, symptomatic improvement (based on categorical
improvement in activity, alteration of mood, comfort, appetite and fluid intake) and clinical
and biochemical adverse effects. The results revealed that fever clearance time (median SE,
95% CI) was comparable between two groups paracetamol; 32 (2, 22-37) h: placebo:36
(1,33-39)h: P=0.23). Paracetamol resulted in significantly higher rate of fall of temperature
(paracetamol: 0.33 +/- 0.16 degrees c/h; placebo 0.07 +/- 0.13 degrees c/h; P > 0.001) and
percentage reduction of temperature paracetamol: 85.4 +/- 22.4; placebo 45.5+/- 34.1; mean
difference 39.9; 95% CI 31.9-47.9; P > 0.001) during first four hours after drug
administration. Proportion of afebrile children after 4 hours paracetamol: 46.6%;
placebo:12.1%; P < 0.001)and symptomatic improvement at 6 hours were significantly higher
( P < 0.001) after administration of paracetamol as compared to placebo. No sessions clinical
or biochemical adverse drug effects were observed. The study concluded that paracetamol
achieves effective antipyretics and provides early symptomatic improvement in children with
febrile illness without prolongation of fever duration or excessive adverse effects18.
6.2.2. Reviews related to paracetamol toxicity in children.
A retrospective cohort study was conducted to investigate the impact of serum
acetaminophen concentration on changes in serum potassium, creatinine and urea
concentrations patients with acetaminophen overdose. With the sample, for a period of 5
years from 1 January 2004 to 31 December 2008. Data are presented as mean + or – SD and
as medians (interquartile range) and groups were compared using independent two-tailed
student T test. The data was analysed by statistical package for social sciences. The results
revealed that 283 patients were studied (44 males and 239 females), mean age 23 + or – 7.5
years. Patients who had a serum acetaminophen concentration above a “possible toxicity”
treatment line were associated with an elevation in serum creatinine concentration (P=0.004)
and a reduction in the serum potassium concentration (P < 0.001) but were not associated
with a reduction in serum urea concentration (P>0.009). During the study period, 63.3% (179
patients) had serum potassium concentrations less than the normal concentration
(2.5mmol/1). The serum creatinine concentration in all patients was within the normal range.
The study concluded that acetaminophen appears to cause a concentration-dependent
reduction of potassium concentrations and an elevation of creatinine concentrations of short
duration (<24h) after over dose19.
A retrospective single-center case study was conducted to investigate the risk of high-
dose ingestion of orodispersible, fast-disintegrating paracetamol tablets in children. With the
sample of 187 cases with ingestion of solid 500mg paracetamol tablets and 16 cases with
ingestion of orodispersible 500mg tablets. The results revealed that the mean ingested dose in
the orodispersible tablet group was 59% higher than in the solid-tablet group (P=0.085).
Administration of activated charcoal and/or N-acetylcysteine because of ingestion of a
potentially hepatotoxic paracetamol dose (more than or equal to 150mg/kg body weight) was
recommended in 32 patients (17.1%) in the solid-tablet group and in five (31%) in the
orodispersible-tablet group. The study concluded that orodispersible paracetamol
formulations may represent an important risk factors for severe paracetamol poisoning in
children and over-the-counter availability may contribute to increasing the use of this
galvanic formulation and eventually the number of poisoning in children20.
A population-based study was conducted to identify the risk of hepatotoxicity in
patients with unintentional over doses of paracetamol, alcohol abuse and underlying liver
disease. With the sample of during the 10 year interval, 1543 patients were hospitalized for
acetaminophen overdose; those patients were identified retrospectively by using International
Classification of Diseases-Nineth Revision-Clinical Modification and International Statistical
Classification of diseases and Health related problems, 10th revision diagnostic codes. The
results revealed that 1543 patients were hospitalized for acetaminophen overdose, 34% were
alcohol abusers, 3% had liver disease and 13% overdosed unintentionally. Seventy patients
(4.5%) developed hepatotoxicity. Unintentional overdose (odds ratio [OR], 5.18; 95%
confidence interval [CI], (3.00-8.95), alcohol abuse (OR; 2.21, 95% CI, 1.30-3.76),
underlying liver disease (OR; 3.50, 95% CI, 1.57-7.77) and N-acetylcysteine treatment (OR;
6.75, 95% CI, 2.78-16.39) were independently associated with hepatotoxicity 15 patients
(1.0%) died in-hospital; risk factors included older age, unintentional over doses, alcohol
abuse, comorbidites including liver disease and hepatotoxicity (14% vs 0.3%; P < 0.0005).
During a median follow-up of 5.2 years (range,1 day-11.0 years), 79 patients (5.1%) died.
The study concluded that the acetaminophen overdose had a relatively benign short term
course but was associated with substantial long-term mortality caused by preventable
conditions and acetaminophen related hepatotoxicity is more common in patients with
unintentional overdoses, alcohol abuse and underlying liver disease21.
A case control study was conducted to evaluate the risk of fulminant hepatic failure in
relation to paracetamol overuse with therapeutic intent in febrile children. Paracetamol
ingestion for the current febrile illness was compared between 25 cases of fulminant hepatic
failure and 33 hospital age matched controls. The results revealed that supra therapeutic doses
of paracetamol (mean 145mg/kg/day) were consumed by all 25cases compared to none in the
control group. Mean paracetamol level in the cases and controls were, respectively, 26.84
mg/dl and 0.051 mg/dl (P<0.001). The mean duration of paracetamol intake prior to
admission in cases was 3.45 days compared to 1.85 days in the control group. Nineteen, 5 and
3 were respectively, graded as hepatic encephalopathy grade 1, 2 and 3. All six patients in
grade 2 and 3 had hepatomegaly compared to 78% in the grade 1. Four had jaundice and all
were in grade 2 or 3. Mean alanine aminotransferase was 2781 U/L. None of the randomly
selected cases (6) had serological evidence of Hepatitis A, Hepatitis B or Dengue. Three
cases died. The study conclude that exposure to multiple supratherapeutic doses of
paracetamol is a risk factor to develop fulminant hepatic failure in children with an acute
viral like febrile illness22.
6.2.3. Reviews related to knowledge of mothers in administration of paracetamol to
children.
A cross-sectional study was conducted to investigate parents accuracy in giving
dipyrone and acetaminophen to their children in a poor region. With the sample of 200
patients, they have documented that a significant percentage of children are given
inappropriate doses of Acetaminophen and Ibuprofen. The main complaint of fever and
atleast one dose of dipyrone or acetaminophen given to the child during the 24 hours
preceding their arrival at the emergency department. The mothers were asked for
demographic information and about the antipyretic doses, which were compared with the
recommended dosage. The results revealed that among the 200 patients studied, 117 received
dipyrone and 83 received acetaminophen. Overall, 75% received an incorrect dose of
antipyretic. Of the patients who received dipyrone, 105 (89.7%) were given an incorrect dose;
16(15.2%) received too little dipyrone and 89 (84.8%) received too much. Of the patients
who received acetaminophen, 45 (54.2%) were given an incorrect dose; 38 (84.4%) received
too little acetaminophen and 7 (15.6%) received too much. There are no differences in
maternal and child characteristics between the groups receiving correct and incorrect doses of
medication, except for the type of medication (dipyrone versus acetaminophen). The study
concluded that most of the children treated were given inappropriate doses, mainly dipyrone
overdosing and acetaminophen underdosing23.
A cross-sectional self reported survey was conducted on 650 parents to assess the
parental decision decision-making with regard to treating fever in children and its
effectiveness and to suggest methods for improving the level of treatment. With the sample of
650 parents who sought medical assistance for a child under the age of 10 years. Parents
represented various socio economic levels, educational back grounds and religious
affiliations. Parents without a basic understanding of treatment principles may give their
children incorrect doses of medication. The results revealed that ninety-six percent of parents
treated fevers that reached 38.50C and 77.6% treated fevers of only 380C. Acetaminophen
was the treatment of choice for 96% and dipyrone for 4%. Parental sources of information for
managing and administering antipyretic drugs were medical personnel (40.7%), mothers or
grand mother’s experience (30%) and the enclosed leaflet or instructions on the bottle
(29.3%). Forty- three percent of the parents administered the recommended dosage (10-
20mg/kg), whereas 24.3% used less and 32.7% used more, 11% exceeded a daily dosage of
120mg/kg. The study concluded that a total of 57% of parents treated children with incorrect
doses of antipyretic drugs. In 11% of the children treated, the daily dose was at a level that
could cause severe toxicity. Parental knowledge of the treatment of fever must be improved.
A cross-sectional study design was used to explore care givers knowledge of
acetaminophen and comprehension of written medication instructions about acetaminophen
syrup when administered to febrile children. With the sample of 102 care givers with febrile
children under 6 years old. A self-designed questionnaire was used to solicit participants
responses concerning approaches to fever management prior to hospital administration and
knowledge and comprehension of antipyretic medication administration. Care givers were
asked to answer specific questions about the instructions provided with the medication. The
results revealed that antipyretic by oral (66%) and antipyretic suppositories (60%) were the
most commonly used forms of fever management in febrile children. After reading the
written medical instructions, one-third of the participants had more than one
misunderstanding of the instructions for medication with timing, time interval of
administration and/or medication dosage. Almost two-thirds of the participants
misunderstood the side effects of acetaminophen. Participants with a poorer academic back
ground were associated with poorer comprehension of the provided instructions. The study
concluded that administration of antipyretic medication is the most common approach taken
to reduce children’s temperature. A significant percentage of primary care givers appear to
lack a thorough understanding of the instructions provided with antipyrexial medication24.
A qualitative study was conducted to explore parent’s knowledge on use of medicine
in relation to their management of common childhood illnesses and the impact of the family.
With the sample of 24 parents was selected for interviews according to their responses to the
questionnaire and family characteristics. Parents of pre-school aged children were asked
open-ended questions about their perception of illness, its impact on the family, the use of the
paracetamol and sources of medical information. The interviews were audio taped. The
results stated that parents recognized illness among their children either intuitively or by
taking notice of specific signs or symptoms. Fever was considered a definite sign of illness,
almost congruent with the disease itself. Some parents acknowledged that low or moderate
fever reflected a battle between the body and the disease-causing organism. Administration of
paracetamol gave parents the feeling of mastery. The medicine was also used to calm down
the child enabling information about child diseases, others were only eager to know more
about it during period of illness and some parents were not interested as they felt information
only caused more anxiety. The study concluded that fever was often judged to cause
discomfort and danger. Thus antipyretics like paracetamol were regarded as a medicine
counteracting disease. Paracetamol constituted an important tool for parents in managing
different upsets during childhood illnesses and knowledge about the significance of fever and
how to handle children during common illnesses might need to be presented in a context
familiar to parents, for instance, in relation to general information on child care25.
6.2.4. Review related to the effectiveness of Structured Teaching Programme.
A quasi-experimental study was carried out to evaluate the effectiveness of structured
teaching programme (STP) on Acute Respiratory Infection (ARI) among mothers of
hospitalized underfive children. After pretest, STP was given with appropriate audio visual
aids. The post test was conducted after three days. The study findings revealed that after STP
there was a significant improvement in the mother’s knowledge, attitude and practice
regarding ARI. Thus it was found that STP was effective in improving the knowledge of
mothers of underfive children26.
A study was conducted to assess the effect of a selected intervention on the nutritional
status of 2-5 year old children in day care centres. Using a longitudinal prospective pretest /
post test intervention design, 974 children from 3-day care centres in Alexandria were
followed for 1 year. Anthropometric measurements and 3-day 24-hour recall data were
gathered at base line and dietary intake was calculated and compared with recommended
daily allowances. An intervention programme was implemented through the establishment of
kitchens in the 3 centres, provision of 2 meals/day, nutrition education for parents and
training of supervisors. Base line data revealed deficient intake of most nutrients especially
calcium, calories, vitamin C and iron. Post-intervention test revealed improvement in
mother’s nutrition knowledge. A decrease in the percentage of underweight, stunted and
wasted was also observed27.
A study was conducted to assess the effectiveness of Structured Teaching Programme
on post natal exercise among post natal mothers in selected hospital, Bengaluru. Maximum
participants were the age group 22-26 years. 35% of them had primary education and 75%
belongs to Hindu religion. The mean pre test was 13.8 and that of the post test was found to
be 22.2. The obtained ‘t’ value 4.77 is found to be greater than the table value and thus it is
conclude that the STP effective in improving the knowledge of post natal mothers28.
In a study conducted to assess the effectiveness of Structured Teaching Programme on
knowledge of mothers of underfive children regarding protein energy malnutrition in selected
hospital, Bengaluru, the overall mean percentage was found to be 35.1% in pre test and 72%
in post test. Hence it is concluded that the Structured Teaching Programme is effective in
improving the knowledge of mothers of underfive children29.
STATEMENT OF THE PROBLEM
A STUDY TO ASSESS THE EFFECTIVENESS OF STRUCTURED TEACHING
PROGRAMME REGARDING KNOWLEDGE ON PARACETAMOL TOXICITY IN
UNDERFIVE CHILDREN AMONG MOTHERS IN A SELECTED COMMUNITY AREA,
BENGALURU.
6.3 OBJECTIVES OF STUDY
6.3.1. To assess the knowledge of mothers of underfive children regarding paracetamol
toxicity by pre test.
6.3.2. To assess the effectiveness of structured teaching programme regarding knowledge on
paracetamol toxicity in children by comparing pre and post test knowledge scores.
6.3.3. To find the association between pre test knowledge scores with selected demographic
variables.
6.4 HYPOTHESIS
H1 - There will be significant difference between the pre and post test knowledge scores
regarding paracetamol toxicity in underfive children among mothers.
H2 - There will be significant association between pre test knowledge scores with selected
demographic variables.
6.5 RESEARCH VARIABLES
INDEPENDENT VARIABLE:
Structured teaching programme on paracetamol toxicity in underfive children.
DEPENDENT VARIABLE:
Knowledge on Paracetamol toxicity in underfive children among mothers.
EXTRANEOUS VARIABLES:
It include demographic variables such as age, education, husband’s education, occupation,
monthly family income, type of family, no. of children and previous source of information
regarding paracetamol toxicity.
6.6 OPERATIONAL DEFINITIONS
6.6.1 Assess: It refers to the way the level of knowledge as expressed by the mothers in
underfive children on paracetamol toxicity as measured by pre-test scores.
6.6.2 Effectiveness: Refers to the extent to which the structured teaching programme on
paracetamol toxicity achieves the desired effect in improving the knowledge and perceived
needs of mothers in underfive children on paracetamol toxicity as evidenced by gain in post-
test knowledge scores.
6.6.4 Structured teaching programme: It refers to systematically developed instructional
method and used for mothers in underfive children to provide information on paracetamol
toxicity.
6.6.5 Knowledge: refers to exact answer from participants regarding paracetamol toxicity.
6.6.6 Paracetamol toxicity: Paracetamol toxicity is caused by excessive use or over dose of
paracetamol administration in children, mainly causing liver and kidney damage.
6.6.7 Children: It refers to children at 0-5 years of age.
6.6.8 Mothers: refers to women who have children between 0-5 years, living in a community
area of Bengaluru.
6.7 ASSUMPTIONS
6.7.1 Mothers of underfive children may have some knowledge regarding paracetamol
toxicity.
6.7.2 Mothers of underfive children may have some interest to know about paracetamol
toxicity and its effects on children.
6.8 DELIMITATION OF STUDY
The study is delimited to 60 mothers of underfive children who are residing in a selected
community area, Bengaluru.
7. MATERIAL AND METHODS
7.1 SOURCE OF DATA
The data will be collected from mothers of underfive children in a selected community area,
Bengaluru.
7.2. METHOD OF DATA COLLECTION
Structured Interview Schedule will be used to collect the data from the mothers of
underfive children.
7.2.1 RESEARCH APPROACH:
Evaluative approach
7.2.2 RESEARCH DESIGN
GROUP PRE TEST TREATMENT POST TEST
1 O1 X O2
The research design for the study will be pre-experimental design, with one group
pre test – post test design.
O1 : Knowledge on paracetamol toxicity among mothers of underfive children by pre test.
X : Administration of structured teaching programme on paracetamol toxicity.
O2 : Knowledge on paracetamol toxicity after the administration of STP by post test.
7.2.3 RESEARCH SETTING
The above study will be conducted at Chandapura, a selected rural community area,
Bengaluru which is 30kms away from The Oxford College of Nursing.
7.2.4 POPULATION
The population of the present study comprises of mothers in underfive children who
are residing in a selected rural community area, Bengaluru.
7.2.5 SAMPLE SIZE
The sample size of the present study consists of 60 mothers of underfive children who
are residing in a selected rural community area, Bengaluru.
7.2.6 SAMPLING TECHNIQUE
Purposive Sampling Technique will be adopted for this study.
7.2.7 SAMPLING CRITERIA
INCLUSION CRITERIA
1. Mothers of underfive children who are willing to participate in the study.
2. Mothers having children between the age group of 0-5 years.
3. Mothers who are available during the time of data collection.
4. Mothers who can understand English or Kannada.
EXCLUSION CRITERIA
1. Mothers of underfive children are not willing to participate in the study.
2. Mothers who are not available during the time of data collection.
3. Mothers who cannot understand English or Kannada.
7.2.8 TOOL FOR DATA COLLECTION
A structured Interview Schedule will be used to collect the data from the mothers of under
five children. It consists of two parts.
Part-I:
Items on demographic variables like age, education, husband’s education, occupation,
monthly family income, type of family, number of children and previous source of
information on paracetamol toxicity among mothers of under five children.
Part-II:
Items on Knowledge aspects regarding paracetamol toxicity in underfive children, which will
include meaning, risk factors of toxicity, pathophysiology, clinical features, diagnostic
measures, management and preventive measures.
7.2.9 DATA ANALYSIS METHOD
Data analysis method will be done through descriptive and inferential statistics.
DESCRIPTIVE STATISTICS
Frequency, mean, median, mean percentage and standard deviation to compute demographic
variables.
INFERENTIAL STATISTICS
Parametric: Paired t-test will be used to compare the pre-test and post-test knowledge
scores.
Non Parametric: The association between the pre-test knowledge score and demographic
variables will be analysed by Chi-square test (X2).
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS, OR
OTHER ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
Yes, the study will be conducted in mothers of underfive children.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM THE
ETHICAL COMMITTEE OF THE OXFORD COLLEGE OF
NURSING?
1. Ethical clearance is obtained from the research committee of The Oxford College
of Nursing, and the copy of the certificate is enclosed.
2. Permission will be obtained from the concerned authorities of the selected
community area, Bengaluru, where the study is schedule to be conducted.
3. Informed consent will be obtained from the mothers of underfive children who are
willing to participate in the study at the time of data collection.
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9. SIGNATURE OF THE :
STUDENT
10. REMARKS OF THE GUIDE : The topic which is selected found to
be appropriate and relevant to impart
knowledge regarding paracetamol
toxicity in underfive children among
mothers.
11. NAME AND DESIGNATION : Mrs. SILVY DAVIS
OF THE GUIDE: Associate Professor.
11.1 GUIDE NAME AND ADDRESS : Mrs. SILVY DAVIS
Associate Professor
Department of Paediatric Nursing
The Oxford College of Nursing
No. 6/9 & 6/11, 1st Cross
Begur Road, Hongasandra
Bengaluru.
11.2 SIGNATURE OF THE GUIDE :
11.3 HEAD OF THE DEPARTMENT
NAME AND ADDRESS : DR. G. KASTHURI
Principal
The Oxford College of Nursing
No. 6/9 & 6/11, 1st Cross
Begur Road, Hongasandra,
Bengaluru – 68.
11.4 SIGNATURE OF THE HOD :
12 REMARKS OF THE PRINCIPAL : The research topic selected is relevant
as it attempts to empower the
knowledge of mothers regarding
paracetamol toxicity in underfive
children.
12.1 SIGNATURE OF THE
PRINCIPAL:
Dr. G KASTHURI
Principal
The Oxford College of Nursing,
No.6/9 & 6/11, 1st Cross
Begur Road, Hongasandra
Bengaluru-68.