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.