Background
Acute otitis media (AOM) is one of the most common diseases in early childhood, causing variety of symptoms. Ear pain is considered as the most important and specific symptom of AOM and parents perceive it as one of the greatest burden in young children with AOM [
1]. Furthermore, ear pain is used as one of the key criteria when defining the severity of AOM, which, in turn, guides the management of AOM [
2]. Consequently, it is crucial to be able to reliably assess whether young children have any ear pain.
The assessment of ear pain is challenging in young, mostly preverbal children. First, they cannot provide self-reports which are often considered a primary source for estimates of pain intensity [
3]. Therefore, the pain assessment is based on the opinion of parents and health care professionals. Ear pain of preverbal children is suggested to emerge as various non-specific symptoms, according to The American Academy of Pediatrics AOM guideline [
2]. Nevertheless, the guideline does not give any instructions how to further convert the non-specific symptoms as mild, moderate or severe pain behavior. The study of Shaikh et al. [
4] suggested ear rubbing and fussiness to be the most important symptoms in influencing parental perception of ear pain in preverbal children with AOM. However, as they stated, their results are preliminary and are based on hypothetical patient scenarios. To our knowledge, the adaptation of pain scales for parental use to assess acute, non-procedural pain in young children in an outpatient setting has not been investigated.
We adapted two well-established pain scales for parent observation. Our primary aim was to investigate whether pain scales are useful tools for parents to detect pain in their young, mostly preverbal children with the parental suspicion of AOM. Furthermore, we investigated which symptoms are associated with moderate/severe pain in young children.
Discussion
Our main finding is that pain scales, namely the FPS-R and the FLACC Scale, might be useful for detecting pain by parents in young children with respiratory tract infection (RTI), either with or without AOM. What is more, without the pain scales, parents may underestimate pain in young children with RTI. Furthermore, nearly all children might suffer from moderate/severe pain or distress during RTI, regardless of the diagnosis of AOM.
Parental pain assessment with the FPS-R and the FLACC Scale indicated that the great majority of the children with RTI, either with or without AOM, seem to suffer from moderate/severe pain. In contrast, when parents were being interviewed about their child’s pain, moderate/severe pain was reported only in two thirds of the children with RTI. The difference in the results between the pain assessment methods is obvious and thus requires further attention. Since the pain results cannot be compared with children’s self-reports of pain, the most reliable pain evaluation method cannot be stated for absolute certainty. It can be debated that in our study, children were conventionally classified as having moderate pain with the FPS-R scores of 4 or 6. On the contrary, the study of Tsze et al. proposes that only children with the FPS-R scores of 6 would be classified as having moderate pain, although considerable overlap of scores associated with mild and moderate pain could be seen in their study [
20]. In our study, however, moderate/severe pain was detected at the similar rate with both the FPS-R and with the FLACC Scale, thus suggesting the reliability of our pain category classification for moderate pain with the FPS-R.
Worth noting, the FPS-R was originally designed and validated to be a self-report measure to assess the intensity of children’s acute pain from age 4 or 5 onward [
9], and it is not validated for the observational use, although faces scales have also been adapted for global observational ratings by parents and nurses [
10,
11,
14,
21]. On the contrary, the FLACC Scale, which was initially developed for evaluating postoperative pain in young children [
15], has further been established as a valid observational measure for all kinds of pain in preverbal children by nurses [
22], although its clinical utility has recently been challenged [
23]. Thus, it should be acknowledged that neither of the pain scales are validated to assess acute, non-surgical pain of young children by parents. Therefore, we can only present preliminary results. For instance, parents may overestimate their child’s pain with faces scales and with the FLACC Scale [
24,
25] although underestimation with the faces scale, as well as with the parental interview have likewise been reported [
11,
26]. However, parents are considered as most reliable proxy for assessing young children’s possible pain, if the self-report is not possible, because children are often more expressive in the presence of parents than strangers, such as health care professionals [
27]. Parents are likewise familiar with the child’s normal behavior and thus they are more able to discriminate child’s pain behavior from other aberrant behavior [
14,
28].
Overall, there seems to be relatively pervasive and systematic tendency for proxy judgments to underestimate the pain experience of others [
29]. However, direct observations of pain behavior and self-reports of pain intensity are more likely to be significantly related to each other, if the individual being studied has acute pain, instead of chronic pain, because nociception plays a greater role in the display of observable behavior among persons with acute pain [
30]. In fact, acute pain of young children has recently been shown to be reliably assessed with the FLACC Scale by nurses [
31]. Taken these findings together, we cautiously suggest that the FLACC Scale might also be used by parents in children with RTI. Since the pain results of the FLACC Scale and the FPS-R were highly similar, this implies that the FPS-R could possibly be applied as the parental pain observation tool as well. Consequently, we suggest that the parental assessment with the FLACC Scale and with the FPS-R might be more useful for detecting pain in young children with RTI, than the parental interview about their child’s pain, because pain scales might better freezeframe a moment for the parents to ponder their child’s pain, than the parental interview.
The occurrence of moderate/severe pain did not significantly differ between AOM and non-AOM groups with any of the three pain evaluation methods. At first sight, this may seem conflicting. However, symptoms of RTI may likewise cause severe distress to young children. In fact, when parents assessed their child’s pain with the FLACC Scale, which is validated to measure distress behavior, nasal congestion had a significant association with moderate/severe pain. Furthermore, ear-related pain may likewise accompany children with RTI due to the blocked ear and dysfunction of the Eustachian tube. Our current results also support our previous findings that symptoms of AOM and RTI are overlapping [
6]. Our study illustrates the difficulties that the parents of young children are facing, when interpreting, which of the child’s symptoms are due to ear pain, or due to distress from RTI. Based on our preliminary results, we suggest that young children with RTI, without AOM, might suffer from equal amount of distress or discomfort as do children with AOM. Thus, when parents suspect their child with RTI to have AOM, we recommend that clinicians would actively offer pain medication, although AOM was not diagnosed. All in all, further studies are needed to investigate the severity of pain and its assessment in outpatient children with RTI.
The key symptoms associating with the parental assessment of their child to suffer from moderate/severe pain were ear pain reported by child and restless sleep. These two symptoms stood out, regardless of the pain evalution method. Indeed, restless sleep or fussiness has also previously been related as suggestive of ear pain in preverbal children [
2,
4]. On the other hand, restless sleep has not been shown to resolve significantly faster with the antimicrobial treatment in children with AOM, compared to the treatment with the placebo [
5]. Thus, this suggests that restless sleep may reflect the general pain and distress due to RTI, for example headache, sore throat or nasal congestion, rather than ear pain specifically. Interestingly, when pain was assessed by parents with the FPS-R, poor appetite seemed to be the sign for moderate/severe pain, although it has more commonly been held as a sign for child’s impaired overall condition. Hence, we suggest that if the validated pain scales are not available in the clinical practice, the clinician could ask about these specific symptoms (such as ear pain reported by child, restless sleep, poor appetite) to interpret whether a child with RTI suffers from moderate/severe pain.
Our study implies that the undertreatment of pain might be prevented in young children with the use of pain scales, such as the FPS-R and the FLACC Scale. This would have consequential impact on young children’s life, because pain experiences in early childhood may induce long-term alterations in pain sensitivity [
32,
33]. Hence, our study might offer a valuable new perspective for clinicians who treat young children with RTI. Pain scales might be used as a simple tool at the primary care to explore the possible need for pain medication. However, more studies are mandatory before implementing pain scales for parental use in clinical practice.
Our study is not without limitations. First, due to the tight schedule at the study visit, we explained the pain scales to the parents very briefly, leaving parents a possibility of misunderstanding of matching the child’s facial expression to the faces in the FPS-R figure, despite the instructions. On the other hand, this reflects the real life in clinical practice and was thus also a strenght. However, it may be argued that the FPS-R is a relatively coarse scale with six categories for adult observers and that they would be capable of finer distinctions, for example with a finer-grained numerical rating scale. Second, to our experience, parents considered the FLACC Scale as challenging, because they had to recall their child’s behavior in each of the five behavioral categories, possibly causing recall bias. Third, the data about parental education level or occupation is missing, which may be seen as a limitation because higher level of parental education has been shown to be associated with higher reported pain levels [
4]. However, our study population came from all the postal code regions of Turku area which shows the sosioeconomic heterogeneity of the population. Nonetheless, our study has also several strenghts. First, the standardized, structured symptom questionnaire allowed us to investigate the symptoms rigorously. Second, parents were surveyed about the symptoms via interview conducted by study physician. This represents well the actual real life situation in the primary care, reflecting generalisability of our results. Third, the diagnosis of AOM is firm due to our careful diagnostics [
5]. This strenghtens our findings that children with RTI seem to suffer from moderate/severe pain, regardless of the diagnosis of AOM.