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.