Knowledge and Awareness of Caregivers About Using Paracetamol in Children in Al-Baha Region: a Cross-sectional Study

Introduction

Over-the-counter (OTC) paracetamol, also known as acetaminophen, is regularly used for children’s pain relief and as an antipyretic due to its efficacy, relative safety, and availability in a range of pharmaceutical forms that includes syrups, drops, suppositories, etc. However, previous research has shown that parents frequently unintentionally give their children an incorrect amount of paracetamol.¹ In this study, we aimed to assess parents’ knowledge, attitudes, and practices regarding the use of paracetamol, as well as their awareness of items containing the active ingredient. According to reports, paracetamol is the most prevalent pharmaceutical agent involved in overdoses, especially in children under age 6.² The variable dosing schedules and strengths of the various formulations of paracetamol pose a serious risk of overdose in children and infants.²

Paracetamol is commonly used for fever which is demonstrated to be a reason for anxiety among parents. Fever accounts for up to 22% of visits to emergency departments (ED).³ Fifty percent of parents treat their child’s fever with the wrong medication dosage.³ Many parents endorse simultaneous utilization of ibuprofen and paracetamol, to lower fever because they dread it excessively.³ Paracetamol poisoning can result from attempted suicide or accidental overdose in children.⁴ Accidental child poisoning in Jeddah was mostly connected with medicinal drugs, with a reported frequency of 23.3%.⁵ Parental education and understanding played a significant influence in decreasing the incidence of child poisoning.⁵ In a survey of 300 parents, most of the caregivers polled (87%) were females (mothers). Approximately half of the parents (50.9%) reported having used paracetamol as an antipyretic in children under the age of 6.⁵ One-quarter (25.4%) favored syrup forms, whereas 33.8% chose suppository dose forms. Roughly half of the caregivers (51.2%) relied mostly on medical staff for information. The average knowledge score for paracetamol was 2.1 (SD = 1.4) out of 6, with a median of 2.0 and an IQR of 1.0 to 3.01. ⁶ Given the lack of existing studies related to our topic and our emphasis on Al-Baha city, our main goal is to assess the level of parental knowledge and awareness regarding the utilization of paracetamol among children in Al-Baha. It is essential to assess parental knowledge to establish whether parents are aware of the correct usage, dosages, potential side effects, and other safety precautions while their children are receiving treatment with paracetamol. This knowledge will add a new perspective to the discourse that could be beneficial to health providers, authorities, and educational programs aiming to ensure the safe administration of drugs to the pediatric populations in Al-Baha city, Saudi Arabia.

Materials and Methods

Inclusion and Exclusion Criteria.

Al-Baha area residents who are parents or caregivers who have legal custody of children between the ages of 0 and 18 years were the target sample group for the study. Persons without children were excluded. Health care providers with children have been included to serve as internal controls.

Sample Size.

The sample size was calculated by utilizing the Qualtrics calculator with a confidence level of 95%; the proposed sample size was 384.

Method for Data Collection and Instrument.

A self-administered electronic questionnaire was constructed and distributed by the research team using a simple random sampling method to parents and health care providers at the clinics. The health care providers included physicians, nurses, and pharmacists. Prior to participation, informed consent was obtained from all respondents, ensuring their voluntary agreement and understanding of the study’s purpose and procedures. The survey took 8 weeks’ time. The questionnaire utilized a modified validated survey from a similar study conducted in Palastine.⁷ It included 4 sections regarding the sociodemographic data, the awareness regarding paracetamol products among participants, parents’ knowledge of paracetamol use, and parents’ paracetamol-related practices and attitudes (see Supplemental Table).

Statistical Analysis

The relationship and incidence of the event have been assessed using the χ². Analysis was performed using the software package IBM SPSS Statistics (SPSS Inc, version 25.0). Differences were considered statistically significant at p ≤ 0.05.

Results

All those approached by the questionnaire agreed to participate in the survey after understanding of the study’s purpose and procedures. Their total number was 1000 participants. The demographic characteristics of the participants in the study are shown in Table 1. The responses reported by physicians were not significantly different from the responses of the parents. Most of the respondents (45.8%) exist in the age range of 18 to 29 years.

Table 1.Demographic Characteristics of the Participants in a Cross-sectional Study About Knowledge and Awareness of Parents About Using Paracetamol in Children in Al-Baha Region KSA

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Some health features of the children studied in the present work are shown in Table 2. 41.9% of parents and 50.8% of physician parent respondents reported administering OTC paracetamol to their children. 27.2% of the parents related this OTC use to their previous experience with similar symptoms in their children.

Table 2.Comparison Between Physician and Global Population (Including Physicians) Regarding Some Health Features of the Children Studied in a Cross-sectional Study About the Knowledge and Awareness of Parents About Using Paracetamol in Children in Al-Baha Region KSA

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The dosing and administration knowledge and practices of parents are shown in Table 3. One-third of the respondents (33.3%) think that the maximum amount to be administered is a 1-time single dose (as opposed to repeated doses for persistent fever); and that the dose quantity is determined by the age of the child, 58.8% think that overdose of paracetamol can harm the child, 60.8% had never administered adult paracetamol pharmaceutic forms to their children, and approximately 26% measure doses using a graded cup or a teaspoon. The parents’ medication preferences and practices are shown in Table 4. A majority (61.3%) of respondents preferred paracetamol syrup over other pharmaceutical forms for their children, 56.9% store the drugs in the refrigerator, 41.2% reported that their children refuse to take medications; 58.3% persuaded their children by encouragement and motivation to take medications. Re-administration of pediatric paracetamol is practiced by 40% of the parents according to the severity of the condition. Physicians were source of drug information with reference to pediatric paracetamol use and dosing in 48.1% of cases; source of obtaining paracetamol itself was physicians’ prescriptions in 51.1% of cases. Thirty-seven percent never share pediatric paracetamol, while 41.4% share the drug among other children of the family.

Table 3.Dosing and Administration Knowledge and Practices of Parents in a Cross-sectional Study About the Knowledge and Awareness of Parents About Using Paracetamol in Children in Al-Baha region KSA^*

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Table 4.Parents’ Medication Preferences and Practices in a Cross-sectional Study About the Knowledge and Awareness of Parents About Using Paracetamol in Children in Al-Baha region KSA

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The participant’s response, regarding the febrile indication of pediatric paracetamol without prescription, is shown in Figure 1. 31.2% estimated 38°C as the febrile point for administration of paracetamol to their children.

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The response of participants, regarding the dosing interval of pediatric paracetamol preparations, is shown in Figure 2. 48.9% estimated the dosing interval at 4 to 6 hours.

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Discussion

Socio-demographic factors, and family caregivers’ psychosocial status, are among the influencing factors on parental pediatric paracetamol administration practices.⁶ The demographic characteristics of the participants in the present study has 2 merit features compared with similar previous investigations; a larger study sample (n = 1000), and a detailed description of the sample. Both contribute to the reliability of the results. A Palestinian cross- sectional study of similar interest, that included 300 participants, reported 87% of the sample being females.¹ This is higher than our female participants of 57.6% of the study sample wherein 32.8% were mothers, 23.6% were sisters and 1.2% were grandmothers. The diversity of caregivers in the family, and the involvement of all family members in the health care of the family children, shows the strength of relationships within the local community. Most of our respondents (72.1% total, 55% of mothers and 51.5% of fathers) are university graduates. 5.7%, including 7.5% of the mothers and 11.3% of the fathers, hold postgraduate degrees. 0.1% of the respondents were non-educated, moreover, 5.3% of the mothers and 2.8% of the fathers of the children are non-educated. Considering that the sample was random and cross-sectional, these results indicate the wide dissemination of education in the local community and contribute to the reliability of the results which depends on understanding and honest questionnaire responses. The educational level of participants in our study is different from that in the Palestinian report, where 55.3% of the mothers reported completing high school education as their highest level of education. They also reported 75.3% of respondents fell into the age range of 19 to 30 years old, whereas only 49.9% of our respondents were in this age range.¹ With age, mothers are expected to collect a build-up of experience pertaining to childcare. Slightly less than half of our sample (48%) have 2 to 4 children, 22.3% have 1 child, and 29.7% have more than 4 children. These determinations are partially consistent with the previous determinations that 33.0% had 2 children below 18 years of age, and 50% had 2 children below 6 years of age.¹ It has been found that 43.2%, 4.6%, 2.4%, and 49.8% of those approached by the study are single, divorced, widowed, or married, respectively. The family monthly income was reported as less than 5K, 5 to 10K, 10 to 20K, or more than 20K SAR for 10.2%, 27.7%, 38.9%, and 23.2% of them respectively. The latter finding is higher than the findings in similar previous investigation in Palestine in which 64% of their sample has a family monthly income of 2K to 5K NIS, that is, 2.066K to 5.165K SAR.⁷ Both the former and latter findings contribute to family stability and general child welfare including health issues.

Among the children included in our sample, it has been determined that 23.7%, 25.5%, and 22.2% (total of 71.4%), have visited a doctor once, twice, or more than 2 times, respectively within the past 6 months. These results indicate that a majority of families rely on health services for their children’s welfare. This percentage is greater than the previous determination that 43.7% of the children had 1 doctor visit in the last 6 months.¹ The frequency of parental treatment of children at home in the past 6 months was 23.7%, 25.5%, 22.2%, for 1 time, twice, or more than 2 times, respectively, compared with none (15.9%). Administration of paracetamol to children without prescription was at 41.9%. The justification of this drug administration was experience with similar symptoms (27.2%), expensive doctor charges (2.5%), lack of confidence in the health care system (1.9%), and denial of the need to visit a doctor (12%). These findings are consistent with those reported by previous studies that 73.4% self-medicated their children without medical advice; that 50.7% self-medicated their children with paracetamol without medical advice; and that the reason for this administration was either having parental experience of treating their children (54.6%) or ascertaining of the child’s illness from symptoms (49.2%)⁷. These findings reflect a high incidence of OTC paracetamol potentially being used incorrectly by parents which poses potential hazards to this especially vulnerable patient population. Earlier investigators had raised alarm against over-the-counter medication for pediatrics, particularly regarding parents’ misinterpretations medications’ labels.⁸ Indiscriminate home medication of non-specific symptoms such as fever should not be encouraged in the presence of remote health care facilities. The available access to these services is confirmed by the present finding that 76.2% of the subject children have been hospitalized before.

As it has been initially proposed, there is an awareness gap regarding paracetamol pediatric use. This is significant regarding the wide use and the ease of access to the drug. Most respondents think that the maximum dose is 1 suppository or a teaspoon-full syrup. This finding is consistent with the previous finding that 61% of the investigated community specify paracetamol dosing interval as 4 to 6 hours.¹ However, there is still a notable number of participants who either believe a shorter or longer time frame is appropriate or are unsure. Most of the respondents (56.1%) think that pediatric paracetamol dose is determined according to age or weight of the child regardless of other determinant variables such as the clinical indication. A previous study had reported similar findings (52.6%).¹ 58.8% think that overdose of pediatric paracetamol can cause harm, wherein only 13% correctly assigned that harm to hepatic injury. This result is consistent with the previous reports that 50.9% of the investigated community is aware of the potential harm of an overdose of the drug¹; that 67.4% of the investigated community believe that paracetamol self-medication is potentially lethal in overdose⁷; or that 25.8% were aware of liver damage as a side effect of paracetamol.⁹ Wherein 16% had previously administered adult paracetamol to their children, 9.3% attributed that misuse to its effectiveness compared with pediatric forms, 9.6% used the full adult dose while 9.3% gave half of the adult dose. This determination is less than a previous report where most parents believed that, for all pills, when split in half, they provide precisely half of the therapeutic dose.⁷ Of those who used a calculated dose (7.4%), only 46.2% used a graded instrument. This finding is less than the previous determination that 64% used a syringe or a graded cup to adjust the dose of paracetamol syrup,¹ and far less than the finding that most 93.8% of the parents indicated their use of the measurement tool available in the medicine packet.⁷ Pertaining to expiration of paracetamol syrup following bottle opening, most of the respondents (38%) assigned the period of 3 months, contrary to an earlier determination of assigning this to the manufacturer expiration date on the bottle by 44% of the investigated sample.¹

The preferred pediatric paracetamol dosage form was syrup (62.3%) followed by rectal suppositories (10.1%). This finding is different from a previous report wherein suppository preference (33.8%) predominated over syrup (25.4%).¹ In an earlier study, it was determined that 33.8%, 25.4%, or 1.7% preferred suppositories, syrup, or drops, respectively.⁹ This finding may be determined by child age group, with suppositories being more commonly indicated for toddlers and infants, while syrups are more appropriate for school age children. 18.6% reported preferring, both forms equally, and only 3.3% preferred neonatal drops. Of the respondents, 19.5%, 16.8%, 11.2%, and 18.7%, owed their preference of rectal suppositories to the age of the child, ease of administration, the doctor’s advice, or effectiveness, respectively. The last finding signals a gap of awareness since the different dosage forms are usually bioequivalent. A similar finding has been reported in a previous study, where 32.8% owed their preference of suppositories to its therapeutic efficacy compared with other dosage forms.¹ It is worth mentioning that the efficacy of this dosage form depends largely on mastering administration technique and the storage of suppositories. Health care instructions, or demonstration (50.6%) had been the source of mastering the technique, and 56.9% kept the medicine stored in the refrigerator. In the instances that children refused to take the medication 41.2% the predominant method used to convince the child to take the medication was encouragement and motivation to take the medicine (58.3%) among other methods. Approximately 7% of respondents reported mixing medication with juice or food which can lead to unanticipated food and/or drug interactions. Former investigators found that 26.5% revert to coaxing and encouraging the reluctant children (36.2%), compared with 24% shifting to suppositories, or 18.8% using force with the child.¹ The latter method (e.g., using force) may lead to more serious outcomes as aspiration pneumonia, physical trauma, or aggrandizement of psychological trauma. The respondents assess severity of the children’s illness (40%) rather than physicians’ consultation (25.4%) for repeated re-administration of pediatric paracetamol. These determinations are consistent with the previous report that 36.9% of parents relay on severity of illness rather than physicians’ consultation (15.1%) for repeating paracetamol administration.¹

Among other sources, physicians are the main source of drug information with the reference to be pediatric paracetamol (48.1%). This finding is greater than a previous finding that 33.4% identified physicians as their source of drug information.¹ Friends and relatives constitute a source for drug information to 2.4% of our respondents. However, non-medically trained friends and relatives are an unreliable source of information, compared with other sources such as the pharmaceutical manufacturer leaflet and can pose hazards to the subject children. Over-the-counter acquirement of pediatric paracetamol is common to 24.9% of our sample, together with another 2.1% obtaining the drug from electronic marketing suppliers. The findings that 51.1% of our sample get the drug after issuance of a prescription order does not ameliorate the seriousness of the situation. It is an important finding that 63% share the drug between their children, for the same child, and relatives and friends’ children once they developed the same symptoms. Similar findings were reported in Palestine,⁷ Korea,¹⁰ India,¹¹ and Yemen.¹² Fever can be presenting symptom for a variety of conditions, the management of each depends slightly on the underlying cause of fever. Regarding the body temperature that indicates administration of pediatric paracetamol, the response of 77.5% of the caregivers was variable between 38°C and 40°C, while 22.5% were unsure. Similar response variations have been reported by previous Malaysian² and Italian¹³ researchers.

Limitations

Limitations of our study include the study type being a cross-sectional study which provides the least level of evidence. Interventional cohort studies may produce stronger evidence pertaining to the same research question. Our study was limited to a single local community, expanding to a greater region and expanding to additional special populations (e.g., geriatric patients) would strengthen the validly of the results. A new questionnaire must be designed and validated to include new domains. Correlation between demographic and respondent responses should have been conducted using logistic regression with a view to find any beneficial association that may aid in clarifying some issues regarding the area under investigation.

Conclusion

A gap exists in parents’ knowledge regarding the rational use of paracetamol for children in Al-Baha region. In as much as paracetamol is widely used, many parents are unaware of the essential drug information. A considerable number of parents depend on non-medical sources for these information. It has been shown that while most parents use paracetamol for their children, a notable number of them do so without medical advice, or share the drug with other patients. Some parents use incorrect dosages, or are unaware of the potential harm of overdose. This shows the need for educational programs to enhance parent’s knowledge and safe use of paracetamol. Educational programs should focus on the risks of overdose and the importance of following recommended dosages. Our data suggest that the OTC dispensing of drugs should be limited until education of their safe use is expanded. Health care professionals roles are important in educating parents during clinical visits. Social media is, yet, an effective tool that can be utilized to disseminate correct drug information is received. If these gaps in parents’ knowledge and practices are narrowed, the safety and efficacy of paracetamol use will be enhanced and better health outcomes will be obtained in Al-Baha region.