ABSTRACT
BACKGROUND AND OBJECTIVES Painful procedures are common in pediatrics and are frequently done without appropriate pain management. This study aims to evaluate the use of both pharmacological (topical lidocaine) and non-pharmacological interventions for painful procedures in children and adolescents in a pediatric ward.
METHODS This was a non-participant observation study conducted in a pediatric ward of a university hospital after training on pain management. Data regarding children’s characteristics, pharmacological and non-pharmacological strategies used, pain assessment, and procedures' characteristics were obtained. Descriptive statistics and bivariate analyses investigated the outcome measure (procedures performed with both strategies) and were calculated in Stata 19.0, considering p<0.05. The Institutional Research Ethics Committee approved this study.
RESULTS Eighty-two procedures were analyzed. The results revealed that topical lidocaine was used in 43 (52.4%), and non-pharmacological interventions were used in 29 (35.3%). In 18 (21.9%), both strategies were used, with health professionals who participated in the training having applied them more frequently (p=0.01), and with lower observed pain scores assessed before (p=0.03) and immediately after the procedure (p=0.01). No difference was observed for procedure duration (p=0.99) or success of the procedure (p=0.47) between the groups.
CONCLUSION Pharmacological interventions prevailed over non-pharmacological approaches. While the overall adoption of both strategies remained low, their use was associated with reduced pain scores, without compromising the duration or success of the procedure.
Keywords:
Child; Pain management; Procedural pain
HIGHLIGHTS
Painful procedures are performed frequently during children's hospital stays
Many of these procedures are carried out without a multimodal strategy
The use of multimodal strategy was associated with team training and had no effect on success or procedure time
RESUMO
JUSTIFICATIVA E OBJETIVOS Procedimentos dolorosos são frequentes na enfermaria pediátrica e muitas vezes são realizados sem manejo da dor. Este estudo teve como objetivo avaliar o uso de intervenções farmacológicas (lidocaína tópica) e não farmacológicas para procedimentos dolorosos em crianças e adolescentes em uma enfermaria pediátrica.
MÉTODOS Este foi um estudo do tipo observação não-participante realizado em uma enfermaria pediátrica de um hospital universitário após um treinamento em dor. Foram obtidos dados referentes às características das crianças, estratégias farmacológicas e não farmacológicas, avaliação da dor e características dos procedimentos. Estatísticas descritivas e análises bivariadas investigaram o desfecho (procedimentos realizados com ambas as estratégias) e foram calculadas no Stata 19.0, considerando p<0,05. Este estudo foi aprovado pelo Comitê de Ética em Pesquisa da instituição.
RESULTADOS Oitenta e dois procedimentos foram analisados. Os resultados revelaram que a lidocaína tópica foi utilizada em 43 (52,4%) e intervenções não farmacológicas em 29 (35,3%). Em 18 (21,9%), ambas as estratégias foram utilizadas, sendo que os profissionais de saúde que participaram do treinamento as aplicaram com maior frequência (p=0,01) e apresentaram menores escores de dor avaliados antes (p=0,03) e imediatamente após o procedimento (p=0,01). Não houve diferença na duração do procedimento (p=0,99) ou no sucesso do procedimento (p=0,47) entre os grupos.
CONCLUSÃO As intervenções farmacológicas prevaleceram sobre as abordagens não farmacológicas. Embora a adoção geral de ambas as estratégias tenha permanecido baixa, seu uso esteve associado à redução dos níveis de dor, sem comprometer a duração ou o sucesso do procedimento.
Descritores:
Criança; Dor procedimental; Manejo da dor
INTRODUCTION
Pain should be considered a multidimensional phenomenon and observed in all its aspects: physical, emotional, social, and spiritual. According to the revised International Association for the Study of Pain, it is “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage”1:14. Painful experiences are common during childhood, whether associated with play, sports, medical procedures, or illnesses, and despite their frequency, continue to be neglected and undertreated. These experiences bring intense suffering to the children and their families. When not adequately treated, they can have negative long-term consequences in both biological and psychosocial aspects, including dysfunctional coping mechanisms for painful experiences and a greater chance of developing chronic pain in adulthood2. Of note, in Brazil, since 1995, pain relief has been recognized as a right for all hospitalized children3.
Procedural pain in children is frequent during hospitalization. Observations of children aged from 28 days to 10 years in an inpatient Brazilian unit revealed that painful procedures ranged from one to 19 per child. Procedures included airway suctioning, insertion of gastric, enteral, and urinary tubes, and capillary puncture. The authors call for attention to procedural pain, as it is a matter of concern4. Pain caused by needles, when left untreated, can lead to lasting consequences such as needle phobia, pre-procedure anxiety, and hypersensitivity to pain (hyperalgesia). Furthermore, this fear can cause patients to avoid medical care, increasing rates of health complications and mortality5. Considering this, a multimodal approach has been proposed to manage pain, including numbing the skin with topical anesthetics, sucrose, or breastfeeding for infants aged from 0 to 12 months, comfort positioning, and age-appropriate distraction6.
Pain management in children involves several actions: pain assessment, control interventions, and documentation. Failure in any of these may compromise the quality of care. The assessment and recognition of pain are fundamental for the application of subsequent interventions, especially to ensure appropriate treatment is provided through pharmacological and non-pharmacological methods7,8. Pharmacological methods consist of using drugs from different classes and with different mechanisms of action to promote analgesia and reduce pain intensity. In turn, the non-pharmacological approach uses patients’ distraction, breastfeeding, suction with sucrose, and positioning, which should be used in conjunction with pharmacological strategies9,10. Despite the existence of these procedures, pain assessment and the adoption of these strategies remain a complex reality in pediatric units, influenced by various factors, ranging from a lack of knowledge and preparation for pain management to even erroneous beliefs on the part of health professionals11.
Regardless of its etiology, certain aspects must be considered in all circumstances to ensure proper pain management. This includes the education of health professionals, adequate pain assessment, patient and parental involvement in treatment, and the ability to adapt and provide a calm environment. Pain related to procedures can result in patient distress and be worsened by a risk factor: anxiety12. Considering this, an instructional therapeutic toy is an important strategy in preparing the child for the procedure to be performed, by promoting anxiety reduction. The professional demonstrates the exact procedure to be performed on a doll, and the child, in turn, can reproduce it, as well as express his/her feelings and anxiety13. Moreover, interactions with parents during painful procedures directly influence the child's response—resulting in coping or distress—and this can be measured in detail by interaction analysis systems14.
Scientific studies report barriers to the implementation of pain management in pediatric practice15, which are influenced by different factors, including the time required for the development of these practices; even though there is evidence that the adoption of strategies, such as the correct use of topical analgesia, results in a decrease in the total procedure time compared to not adhering to any strategy16. Also, health professionals question the validity of the scales and still state that they take too long to apply17.
The purpose of this prospective study was to evaluate the use of both pharmacological (topical lidocaine) and non-pharmacological interventions for painful procedures in children and adolescents in a pediatric ward.
METHODS
Study design & setting
A prospective non-participant observer study was conducted after education of health professionals regarding painful procedures, aiming to improve participation and education of children and parents, pain assessment, pharmacological and non-pharmacological interventions, and the use of instructional therapeutic toys. Analysis of before-and after-training results is beyond the scope of this study. As the ward did not have a formal protocol, we provided training before data collection. The scenario is a pediatric ward of a university hospital located in São Paulo, Brazil. This study was approved by the Research Ethics Committee (CAAE 81451624.6.0000.5504), and all participants signed the Free Informed Consent Form.
Participants
After training, provided between February 5 and February 17, 2025, patients who were submitted to painful procedures were invited to participate. The included participants were observed between March and September 2025, and these procedures were registered in the research chart, which was built in REDCap (Research Electronic Data Capture). Inclusion criteria were painful procedures (arterial puncture or venipuncture, heel prick, gastric or vesical catheterization) performed in children aged > 30 days and < 12 years, who were not submitted to sedation or systemic analgesia, with participants and/or parents’ agreement. The exclusion criteria were any condition that could impair the patient’s use of topical lidocaine, other painful procedures, cognitive impairment, or use of sedative drugs.
Measures
Demographic questions, information about the procedure, length of procedure, success (yes/no), assessment of pain before and after the procedure using a pain scale, use of topical lidocaine, use of a non-pharmacological strategy, use of the instructional therapeutic toy, and explanation about the procedure to the patient or parents were investigated. The observer assessed pain before and after the procedure. The outcome measure was a procedure performed with the use of topical lidocaine and at least one non-pharmacological intervention (yes/no).
Procedures
Fifty-seven health professionals (nurses, nurse technicians, pediatricians, and respiratory therapists) were trained, divided into six local sessions, on different days, for approximately 20 minutes each. The training was managed by the researchers and considered the recommendations of the Society of Critical Care Medicine and the recommendations from the Brazilian Pediatrics Society9,18. The use of instructional therapeutic toys was recommended. These toys were available at the toy library located in the pediatric ward, organized in boxes, and identified according to age. The team had total access to them. A summary of recommendations, which included the participation and education of children and parents, pain assessment, and pharmacological and non-pharmacological interventions, is in Table 1. In this study, suction with oral glucose was considered a non-pharmacological intervention, following the guidelines of the Society of Critical Care Medicine9.
After the training, painful procedures were observed. A convenience sample approach was employed for the observed procedures. Patients and parents were recruited by invitation in person. No identifiable data was collected, and confidentiality and anonymity were maintained throughout. The REDCap database was used for data collection. REDCap is a secure, web-based software platform designed for building and managing databases, primarily for all research studies. Safeguarding measures included limited access through a secure password.
Sample size
Sample size was based on feasibility. Due to limitations in time, it was deemed that a sample size of at least 50 procedures was feasible.
Pain assessment
Children aged < 3 years were evaluated by the FLACC scale. It was expected that health professionals would use the scale before and after the procedure and register it in the medical chart. The observer applied the scale and registered the result in the research chart, which was used in the analysis.
Children aged between 4 and <8 years were evaluated by the Faces scale. It was expected that health professionals would use the scale before and after the procedure and register it in the medical chart. The observer applied the scale and registered the result in the research chart, which was used in the analysis.
Children aged > 8 years were evaluated by the visual analogue scale (VAS). It was expected that the health professional would use the scale before and after the procedure and register it in the medical chart. The observer presented the scale to the child and registered the results in the research chart, which was subject to analysis.
Statistical analysis
Data was extracted from REDCap to Stata 19.0 for analysis. Normality was tested by the Shapiro-Wilk test. Descriptive statistical analysis was undertaken, with calculation of medians, interquartile range (IQR), and frequencies. The outcome measure was the use of topical lidocaine and a non-pharmacological intervention (yes/no). Comparison between frequencies was calculated by the Fisher exact or the chi-squared test, and between medians by the Mann-Whitney test. Paired medians (sequential pain assessment) were compared by the Friedman test or the Wilcoxon test for paired measures. For all analyses, the statistical significance level was set at 0.05.
RESULTS
Participants and procedures
A total of 82 procedures, performed on 61 patients, were included. In 53 (64.6%), the health professional has been trained. Median patients’ age was 11 months (IQR 5-39), and 34 (55.7%) were male. Eight children (13.1%) had chronic disease, and 43 (70.5%) had previous experience with a painful procedure during that admission. None of the patients presented with frailties or injuries that would contraindicate the use of topical lidocaine.
The observed procedures were 56 venipunctures (68.3%), 12 (14.6%) arterial punctures, 8 (9.7%) gastric or enteral tube insertions, and 6 (7.4%) bladder catheterizations (Figure 1). Most procedures (67; 81.7%) were performed on children under 4 years of age.
Use of an instructional therapeutic toy and explanation about the procedure to children and their parents
Instructional therapeutic toys were used in 4 (4.9%) procedures. Health professionals explained the procedure to children in 27 (32.9%) and to parents in 38 (46.3%).
Pain assessment by health professionals
In 6 procedures (7.3%), pain was assessed by the health professional with the recommended scale before and immediately after the procedure. In only one procedure the health professional assessed pain 10 minutes after. We observed that the median duration of procedures with pain assessment before was 2 minutes (IQR 1-10) and immediately after was also 2 minutes (IQR 1-9). No difference was observed in the duration between the procedures with or without pain assessment, either before (p=0.46) or immediately after (p=0.25).
Pain assessment by the observer
Pain assessed by the observer revealed that immediately after the procedure there was an increase in pain scores (Figure 2). Before the procedure, the median pain score was 2 (IQR 0-5), immediately after was 4 (IQR 2-6), and 10 minutes after was 0 (IQR 0-0).
Use of pharmacological and non-pharmacological methods
Of the 82 procedures, topical lidocaine was used in 43 (52.4%). Non-pharmacological interventions were used in 29 (35.3%) procedures. Of these, 17 (58.6%) used 25% oral glucose with suction, and none used breastfeeding; 8 (27.5%) used distractions, and 4 (13.7%) used virtual reality glasses. We observed the interventions used by procedure (Table 2).
In 18 (21.9%) procedures, both strategies were used. Differences were observed for health professionals who participated in the training and pain scores assessed by the observer before and immediately after the procedure. No difference was observed for procedure duration or success or children who were observed more than one time (Table 3). The comparison of pain scores before and immediately after revealed no differences when both strategies were used (p=0.13), unlike others (p=0.005).
DISCUSSION
In this study, where painful procedures were observed in a pediatric ward, most of the painful procedures were venipunctures in children with a median age of 11 months. The use of instructional therapeutic toys was low, and most of the procedures were performed without the use of a pain scale. The use of topical lidocaine was 52.4%, non-pharmacological interventions were 35.3%, and both strategies were used in 21.9%. More trained health professionals used both strategies, and pain assessed before and after the procedure was higher for the procedures that did not comprise both strategies. No difference in the procedure’s duration or success was observed, according to the use or non-use of both interventions.
Venipunctures represented 68.3% of all painful procedures, and the median age was 11 months. These results are in line with literature. A study that evaluated the documentation of painful procedures in hospitalized children also found that the most frequent painful procedures are those involving needles, the main one being venipuncture19. Nascimento et al. pointed out that peripheral intravenous catheterization in pediatrics is frequent, more difficult than in adults, and there should be a concern with pain20. Regarding age, Candido and Tacla21 observed that the most prevalent age range of hospitalized children was 0 to 2 years, with a rate of 48%, followed by the 3-to-7-year age range, which represented a rate of 33%. These results suggest that more attention regarding pain approaches should be paid to venipunctures performed in younger children in this pediatric ward.
The use of instructional therapeutic toys and explanation of the procedure for children and parents was low. Difficulties and barriers to the implementation of therapeutic toys in clinical practice have been reported in the literature. Although nurses generally recognize the effectiveness of therapeutic play in reducing fear, anxiety, and resistant behaviors during invasive procedures, its implementation remains limited and inconsistent. Studies indicate that the main barriers include available time due to heavy workloads, high patient demand, insufficient staffing, scarcity of appropriate playful materials, inadequate physical infrastructure, and the absence of institutional protocols that formally incorporate therapeutic play into routine care. Additionally, some professionals perceive this intervention as primarily belonging to other disciplines or report feeling insufficiently trained and insecure about applying therapeutic play techniques in clinical practice. These factors contribute to the underutilization of this evidence-based strategy, despite its demonstrated benefits for pain management and improvement of the quality of pediatric care22,23. Considering these results, in the pediatric ward, protocols including the use of instructional therapeutic toys should be implemented, including strategies to improve communication with children and families, and also, create a bond between the child and the professional.
Pain scales were used at a low rate and this has been reported in literature. In a retrospective study performed in Kenya, the frequency of documentation of assessed pain in pediatrics varied between 5.7% and 31.4%24. Yuan25 observed that despite educational interventions, there has been no increase in the use of pain assessment tools, demonstrating need for improvement in this area. Unlike the present study, in which procedures were observed directly, a survey study investigated nurses’ perceptions regarding knowledge and attitudes towards pain management, concluding that insufficient knowledge and attitudes that did not reflect best practices are a matter of concern, including appropriate pain assessment26. Souza et al.27 reported subjectivity, distrust, and low documentation of pain scores in pain assessment of hospitalized children. Finally, Azevedo et al. conducted a descriptive and qualitative study to investigate nurses’ knowledge about pain scales in pediatrics. Lack of knowledge of professionals about assessment instruments and their lack of application in the hospital environment were identified among the categories that emerged, signaling that more knowledge is necessary about this issue28. The low rate observed for pain assessment is also concerning and requires further approach through other educational strategies and quality evaluation in the observed unit.
The use of topical lidocaine was 52.4%, and non-pharmacological interventions was 35.3%. If we had considered oral glucose administration as a pharmacological intervention, this rate would have been even higher. This result points to a preference for pharmacological interventions for pain relief in the studied ward and is aligned with the results of Lopes et al.29 about nurses’ perceptions of pain management in children. The authors conducted a qualitative study through thematic analysis and observed that health professionals think that non-pharmacologic methods are more adequate for neonates and that, for older children, pharmacological methods are preferred. In a retrospective study, Carvalho et al. observed in a pediatric unit that during admission, 81.7% of children received a pain relief drug, but only 0.4% of children received non-pharmacological pain management30. Souza et al. also observed that health professionals overvalue pharmacological interventions, although they have autonomy for non-pharmacological methods, which are simple, viable, low-cost, effective, with high-quality evidence and strong recommendations27. On a clinical basis, this result emphasizes the need to reinforce knowledge about non-pharmacological strategies for pain relief and a multimodal approach for pain management.
Topical lidocaine and a non-pharmacological strategy were used together in 21.9%. This result is concerning as the IASP and the European Pain Federation recommendations aligned with the “Children’s Comfort Promise” intervention regarding painful procedures, especially needle pain, advocate for the use of a bundle of 4 evidence-based modalities to all children: topical anesthesia, sucrose or breastfeeding for infants aged < 12 months, comfort positioning, and age-appropriate distraction, as they result in better outcomes10,31. Guimarães et al. presented the process of elaboration of a bundle for pain management in children undergoing venipuncture through a convergent care research method. The bundle included child positioning, distraction, breastfeeding, a sweet-tasting solution with or without non-nutritive suction, and topical anesthetic usage, but they did not report the bundle adherence rates32. Souza et al.27 pointed out that the resulting clinical practice in pain management is highly influenced by health professionals’ attitudes, such as devaluation of interventions and a need to resignify barriers to pain relief. To achieve this, there is a need to integrate actions that focus on professionals’ meanings regarding the pain phenomenon and its context. For the authors, a clinical protocol is essential, but it is not enough. Quality improvement initiatives have resulted in good adherence to ≥ 2 interventions for pain management during procedures in children with cancer33. On the other hand, in a pre- and post-intervention study informed by the Health Quality Ontario Quality Improvement (QI) framework, pain management strategies in hospitalized children were infrequently used during needle-related procedures at both time points, revealing that good results are not easily achieved19. A multimodal approach combining pharmacological and non-pharmacological strategies is the goal and should be achieved in the studied pediatric ward, but we acknowledge that this is not easy.
More health professionals trained used both interventions. It is well known that training improves knowledge. Lopes et al.29 found that health professionals' difficulty in applying non-pharmacological strategies is related to a lack of information and knowledge about these methods, reinforcing the importance of training to improve practice. Yuan's findings corroborate this assertion. When analyzing the impact of educational interventions on pediatric pain management, she found that, following the intervention, there was a significant improvement in knowledge and attitudes related to pain management, including greater capacity to adopt both non-pharmacological and pharmacological strategies25. Although we cannot infer causality, the results of the present study are aligned with the existing literature according to the association between training and better pain practices.
Pain assessed before and after the procedure between the groups was higher for the procedures that did not comprise both strategies. Also, the comparison of the before and after scores within the groups revealed differences when both strategies were not applied. This result is in accordance with literature. Friedrichsdorf et al.6,10 observed that after the implementation of a pain management protocol which included 4 strategies, the Children’s Comfort Promise, patient and parents’ satisfaction increased. Considering needle procedures performed in children with cancer in Low- and Middle - Income Countries, a scenario different from the present study, the implementation of the Children’s Comfort Promise resulted in a pain reported reduction from 61.7% to 32.1%, and most of all, 94.7% of patients reported that the team did everything in their power to address the pain33. We should acknowledge that in the present study, the number of procedures with both strategies was low, and this may have influenced the results. This result suggests that there is a need to systematically implement pain management protocols in the pediatric ward, as they are associated with lower pain scores.
No differences in the procedure, duration or success were observed according to the use or non-use of both interventions. This suggests that when performing them, health professionals will not have difficulties in managing time. A systematic review that analyzed venipuncture procedures in children with audiovisual distraction observed no differences in the procedural time with the use of distraction. The authors discuss that this result may be explained by the small number of cases included34. On the other hand, Gerard et al.35 observed the positive effect of using virtual reality glasses in surgical patients aged between 5 and 16 years, which resulted in a shorter time required to perform the procedure compared to the control group. Friedrichsdorf et al.6 observed after the implementation of a protocol for pain management that nursing time decreased. These results suggest that there is no difference in the duration or success of procedures according to applying a multimodal approach. On a clinical basis, it is important to discuss these results with the multiprofessional team, aiming to deconstruct erroneous ideas.
It is important to acknowledge some limitations in the present study. As a single-center study with a convenience sample, its results impair generalization. Another limitation is the small sample size, impairing a more robust analysis between groups. The nonrandomized observations and the fact that some patients were submitted to more than one procedure may have influenced the results. The observational design and lack of multivariate analysis impair the evaluation of causality. Results suggest associations, not causality between training and the observed procedures. On the other hand, pain management was evaluated directly by observation and not by health professionals’ or patients’ perceptions. Future research should consider a larger sample size and different pediatric scenarios to inform these practices widely.
CONCLUSION
The present study evaluated pain practices in a Brazilian pediatric ward. Pharmacological strategies prevailed over non-pharmacological strategies. While the overall adoption of both strategies remained low, we observed differences in the proportion of health professionals trained and the others. Reduced pain scores were observed before and after the procedure, without compromising the duration or success of the procedure. Although these findings should be interpreted cautiously, they contribute to the increasing body of literature that points to the urgent need for systematic implementation of better pain management practices in the pediatric scenario and that these practices do not seem to overload health professionals.
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Data availability
References
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