Self-Medication for Toothache in Children: A Cross-Sectional Study

Objective: To construct, validate, and apply a questionnaire to assess and characterize the practice of self-medication performed by parents or children's guardians undergoing dental care. Material and Methods: A questionnaire was constructed, validated


Introduction
The World Health Organization (WHO) addresses the concept of self-medication as the use of medication to treat self-diagnosed disorders or symptoms, either the intermittent or continuous use of prescribed drugs for chronic or recurrent illnesses or symptoms [1,2].The acquisition of over-the-counter medications, the reuse of old prescriptions, the sharing of prescriptions among family members and social circles, the use of leftover medications, and even the failure to comply with professional guidelines, extending or prematurely terminating the dosage and time of use indicated in the prescription, are examples that configure the practice of self-medication [3,4].Consequently, problems arising from self-medication include increased error in disease diagnosis and inadequate treatment of diseases due to the masking of symptoms, excessive or insufficient dosages, and the appearance of undesirable effects and allergic reactions [4,5].In the contemporary scenario, the habit of self-medication through over-the-counter medications is frequent due to easy access and media marketing.
Generally, these medications only treat symptoms and should be used for a short period to treat conditions that do not present significant risks [6].
The practice of self-medication becomes even more critical when it involves children [2,7].The doses used in most pediatric drugs are extrapolations from doses to adults, and the disregard of physiological differences between adults and children can increase the risk of intoxication and the lack of proof of efficacy and safety [8].Children are often excluded from clinical trials for the development of new drugs for ethical and legal reasons, which generates the use of medications in an empirical and often questionable way in this group [9].In addition, children are more susceptible to adverse drug effects due to particularities related to physiological and pharmacokinetic aspects, which are dynamic and change during such development [10].Studies have shown that most of the time, the children's guardians have inconsistent and insufficient medication information but still practice self-medication in their children [11].This practice is motivated by the search for relief of signs and symptoms, and mainly anti-inflammatory, analgesic, and antimicrobial drugs are used [2,7].
Regarding oral health, studies have shown that pain relief and discomfort related to tooth eruption [12] and toothache [13] were the main reasons for parents or guardians to self-medication in children.In Brazil, the practice of self-medication in situations involving oral health is carried out mainly by low-income people, with a wage gain of less than three minimum monthly wages, due to the difficulty in accessing dental services, purchasing medications, and receiving professional guidance [2,7,14].
So far, the literature on studies evaluating the practice of self-medication in children with dental needs is scarce.Thus, a better understanding of this issue involving public health can provide data about its occurrence and guide educational measures for patients and families.
This study aimed to construct, validate and apply a questionnaire to assess and characterize the practice of self-medication performed by parents or children's guardians undergoing dental care in situations that involved problems related to oral health.

Participants
In Step 1, five judges were selected, and the inclusion criteria were being a university professor in any area of health, a kindergarten teacher, a dental surgeon who frequently sees children, or a parent and/or guardian of children aged 0 to 12 years old.Exclusion criteria for judges were functional illiteracy or demonstration of difficulty in reading and understanding texts.The forms for the judges were sent and returned between March and April 2019.
Step 1 -Elaboration, Construction, and Validation of the Questionnaire Initially, a discussion was held between the research team, which supported the construction of the questionnaire.The initial version of the questionnaire had 12 questions, divided into three domains: A -Indication of medication use; B -Route of administration, dosage, and pharmaceutical form; C -Knowledge about the safety of medication use in children.In addition, questions were asked to characterize the sociodemographic profile of the study participants.Five judges (one kindergarten teacher, one pediatric dentist, one pediatric nurse, one mother -housewife -and one physician general practitioner) were invited to rate the questions as relevant or irrelevant.They were able to add comments and suggestions.The Content Validity Index (CVI) [15] was calculated for each question.Questions that obtained a CVI more significant than or equal to 80% were accepted, questions with a CVI less than 80% and greater than or equal to 50% were rephrased, and with a CVI less than 50% were discarded.The comments were used to restructure the issues, and the final version of the questionnaire was not resubmitted for judges' evaluation.
Step 2 -Application of the Questionnaire At this stage, parents or guardians were invited to participate, and those who accepted were individually interviewed after signing the Informed Consent Form.Each interview lasted approximately 30 minutes and was carried out by the researcher in a reserved room while they were waiting for assistance.The researcher read each question to the participant and wrote down the answer.The study participants were interviewed between August 2019 and November 2020.

Sample Size Calculation
The following parameters were considered to obtain the sample size: 0.6 prevalence (p), 5% confidence limit, 95% confidence interval, and a 1.0 effect design [16].The p used for the calculation was based on Brazilian studies on children's self-medication in dentistry [2,7], as the prevalence of self-medication was considered the study's main outcome.Considering a sample size of 95 participants was obtained, with 10% added for compensation of potential losses, the total number of participants was 105.

Statistical Analysis
Data from the sociodemographic profile and the three domains (A, B, and C) were presented as descriptive statistics.For the analysis of the answers related to domains A, B, and C, only the complete questionnaires for each were computed.Domain C consisted of four questions, each with dichotomous answer alternatives (true or false) about the participants' knowledge about using medications in children.In order to obtain the percentage of correct answers in domain C, one point was assigned for each correct answer and no point for each incorrect answer.The minimum and maximum scores were, respectively, 0 and 4 points.
The chi-square test (significance level = 5%) was used to analyze factors associated with self-medication.
The prevalence ratio (95% CI) was used to analyze categorical variables.Data were tabulated and analyzed using the Numbers program for Mac version 10.3.9 (7029.9.8).

Results
All five judges accepted the invitation.Out of the five judges, four were female and one male.The mean age of the judges was 40 years (±8 years), with a mean of professional experience of 16 years (±8 years).Out of the twelve questions assessed by the five judges, three were judged as "little relevant" by two of the five judges; the remaining nine questions were considered as "relevant ."Onlytwo questions received no change suggestions.
After tabulating the data, the CVI was calculated for each item assessed by the judges.Nine questions were kept (CVI = 100%), three were discussed and rephrased (CVI = 60%), and none were excluded.Out of nine questions, six underwent changes according to the comments suggested by the judges.The CVI and the final status of each question are shown in Table 1.Out of the 106 participants approached to perform Step 2, all accepted the invitation to participate in the study.Only one participant was excluded for having already answered the questionnaire prior due to the treatment of her other child.
Most participants were women, and mothers of the children attended.The average age of parents or guardians was 37 ± 9 years.The most prevalent educational level was complete high school (40%), and the average family income was 1.88 Brazilian minimum wage (Table 2).The data related to the practice of self-medication are presented in Table 4.Most respondents mentioned the presence of dental pain in children.There was a higher prevalence of self-medication when family members had a toothache (73.33%), justified by the difficulty in accessing dental treatment.Four questions in domain C measured the degree of knowledge of parents and guardians about the risks of self-medication in children.The average of correct answers in relation to the scores obtained by the respondents' correct answers was 3.99 (±0.10), indicating a high level of knowledge about the topic.However, concerning the pediatric dose used, only 13% of the respondents claimed to use information from the package insert.Half of those interviewed said they used the dose prescribed by the health professional, and 22% used one drop for every kilogram of body weight.Still, 5% claimed to administer the drug directly to the painful tooth.As for the storage location of medicines, despite answering that medicines should be out of reach of children, most reported keeping them in the bedroom or kitchen, which, generally, can be easily accessed by them.Table 4 shows the respondents' answers to the questions related to Domains A, B, and C.There was a significant association between the practice of self-medication administered to children by parents and guardians and their continuous use of medication (p<0.05); and to children who had or had already had a toothache (p<0.01)(Table 5).The other variables studied did not show a significant association with the practice of self-medication.

Discussion
Our study showed that parents and guardians of children undergoing dental care practiced selfmedication in nearly half the cases.According to the participants, most children had already presented toothache previously or at the current time; and the main reason given by the respondents was the difficulty in accessing dental treatment.Despite the undeniable importance of oral health, according to the current Brazilian reality, it is still a frequent habit to seek dental care only in cases of pain or discomfort due to difficulty accessing the dentist [17].Still, self-medication was evident as a family practice since there was an association between its occurrence among members of the family nucleus and the child.
However, self-medication for dental pain in children does not occur exclusively in Brazil and still occurs today.International studies have shown its occurrence in 70% of the Romanian [18] and Turkish [19], 58% in Pakistan [20], 53.8%, 45% in Denmark [21], and 25.2% in Germany [22].In Brazil, it was observed in 56% of participants [2] to 67.2% of cases of dental pain in children treated at the Infant and Pediatric Dental Clinic of the Faculty of Dental Sciences of the Federal University of Rio Grande do Sul and in the public system at CEMO (Medical and Dental Clinic for Children in Belém do Pará), respectively.In most cases, self-medication for toothache alone is ineffective, requiring professional intervention to analyze the symptoms [23].It is important to emphasize that analgesic medication can be used in children in the family environment in cases of dental pain.
However, it must be performed correctly until dental care is provided, as it is essential.Studies have shown that the prevalence of self-medication was higher among parents with a higher level of education [18,22,24], with the possible explanation being the belief in sufficient knowledge to administer medication to their children.
However, in our study, no statistical association was found between the practice of self-medication and socioeconomic and educational features, as in the studies conducted by [19,21].We observed that most children went to the dental appointment accompanied by their mothers, who are often more present during oral health treatment than their fathers or other guardians [18][19][20][21]24].
One of the possible problems arising from the practice of self-medication is drug intoxication.In Brazil, the National Toxic-Pharmacological Information System (SINITOX) of the Oswaldo Cruz Foundation (FIOCRUZ) showed that medicines were the causative agents of 27.1% of the intoxications that occurred in the country in 2017, with a high prevalence in children aged 1 to 4 years of age (18.07%) [25].In this age group, the misuse of medications may come from self-medication practiced by parents or administration or prescription errors made by health professionals.In our study, 12.4% of the children had been intoxicated by medications administered to treat systemic diseases and about 1% for treating dental problems.Furthermore, there was an association between the practice of self-medication in children and the continuous use of medication for the treatment of systemic diseases, which raises the hypothesis that the routine administration of medication to children, even for reasons of systemic health, encourages parents and guardians to practice self-medication for other purposes as well.
Even though the knowledge demonstrated regarding the safety of medication use in children through the four questions applied on such theme, there was a decoupling between discourse and practice since respondents claimed to use incorrect doses and routes of administration, such as the storage of medication in places easily accessible to children.For pediatric patients, the dosage of the drug must be carefully calculated, in relation to weight or body surface, as there are no standardized doses for children as in adults [26].There is often a misunderstanding that 1 milliliter is invariably equivalent to 20 drops and that the dosage to be administered is always one drop per kilogram of body weight.However, the number of drops that correspond to each milliliter may vary according to the prescribed drug [27].
Concerning the drug resolution of odontogenic pain, dipyrone and paracetamol were the most used nonopioid analgesics, as in other studies [2,23].Dipyrone and paracetamol are non-opioid analgesics routinely used in Brazil, over-the-counter, and referred for the treatment of low-intensity pain [26].Despite being drugs that do not depend on a formal prescription for their purchase, it is essential to consider the possibility of adverse effects resulting from an overdose, such as hypotension, nausea, and vomiting, as the incorrect use of dipyrone for the treatment of fever in 77.6% of children attended at an emergency medical care unit was observed, concluding that it is necessary to provide guidance to those in charge for the use of the medication [28].Despite frequent prescribing of acetaminophen, the rate of severe toxicity in children remains rare, such as hepatotoxicity, which occurs mainly when doses above the permitted limits are given, especially frequently.Gastrointestinal disorders, asthma crises in susceptible patients, and cardiovascular events may also occur [29].It is worth mentioning, however, that all the risks present in adult self-medication are potentiated in pediatrics since children have a greater vulnerability regarding their body and a faster and more intense response to medication, which can aggravate a clinical picture, leading to episodes of intoxication and poisoning, severe allergic reactions and even death [30].
Among the study's limitations, the use of a non-probabilistic sample is mentioned.Additionally, the scope of this study was restricted to the only two educational institutions present in the Federal District, a private and a public one, and which attended specific audiences.Thus, there is no way to extrapolate the results obtained to other regions with different socioeconomic and cultural aspects.However, as a positive aspect, it is important to emphasize that this was the first cross-sectional study on the subject in the Federal District.
In summary, considering the results of our study, it is necessary that the health professional correctly prescribes and advises on the use of analgesic medications for pediatric use, even if they are sold over the counter.
The professional's orientation when delivering the drug prescription is the paramount step in the rational use of Design and Location This is a cross-sectional study.The study consisted of two steps, the first consisting of the development and validation of a questionnaire (Step 1) and the second step for its application to children's guardians treated at the Dental Clinic of the University Hospital of Brasília (HUB) and the Catholic University of Brasília (UCB) (Step 2).This study was approved by the Research Ethics Committee of the School of Health Sciences of the University of Brasília (CAAE 10194819.6.0000.0030,opinion number 3.963.823).
Has your child ever had or does your child have a toothache?Yes 69 (65.7)No 36 (34.3)Domain A -Indication of medication use In the family, when medication is needed for toothache and dental infection, do you use medicines on your own?Yes 77 (73.3)No 28 (26.7)Why is self-medication practiced in the above situation?It doesn't apply to the situation 30 (28.6) Due to difficult access to the dentist 52 (49.5)I feel safe about using medication administration 13 (12.4)Someone I know suggested it to me 2 (1.9)I give the medicine based on the old prescription I already had at home 5 (4.8)Others 3 (2.9)When your child or the child under your care has a toothache, do you give them any medication?Yes 52 (49.5)No 53 (50.5)What medication do you usually use when your child has a toothache or a dental problem?It doesn't apply to the situation 47 Route of administration, dosage, and pharmaceutical form When your child or a child under your care has a toothache, how do you administer the medication?It doesn't apply to the situation 44 (41.9)I give it to him(her) directly in the mouth 32 (30.5)I give it to him (her) to swallow with water 20 (19.1)I pour it or place it directly on the tooth 5 (4.8)Other 4 (3.8)What dose do you use when you administer a drug to your child or the child under your care?It doesn't apply to the situation 1 (1.0)The same one I use for an adult (for me, for example) 0 (0.0) Half the dosage I use for an adult (for me, for example) 6 (5.7)I use the dosage prescribed by the doctor or dentist 49 to have information from a friend 0 (0.0)I ask an older family member or a more experienced person 3 (2.9)I try to contact the dentist or the doctor 1 (1.0)I read the medicine package insert 13 (12.4)Other 4 (3.8)I give one drop of medicine per kilogram of the child's weight 23 (21.9)Domain C -Knowledge about the safety of medication use in children Any medicine that can be used in adults can also be used in children.True 1 (1.0)False 104 (99.1)The same dose used in adults can also be used in children.True 0 (0.0) False 105 (100.0)When giving medication to younger children, you need to be more careful as they can get side effects from medications more easily.True 105 (100.0)False 0 (0.0) Medicines can be kept within reach of children at home.True 0 (0.0) False 105 (100.0)Where do you keep medications in your house?Bathroom 0 (0.0) Kitchen 45 (42.9)Bedroom 40 (38.1)They are scattered around the house 2 (1.9)In clothes pockets 0 (0.0)In a purse 1 Has your child ever had any reaction or intoxication when they were given medication for dental pain or infection?Yes 1 (1.0)No 104 (99.1)When your child was given any medication for a health problem, did they ever experience any reaction or intoxication Pesqui.Bras.Odontopediatria Clín.Integr.2023; 23:e220061

Table 3
summarizes the characteristics of the children under dental care at the HUB and UCB whose parents or guardians were interviewed.The average age was 7 ± 3 years.