Effective management of procedural pain is a critical yet often overlooked component of pediatric healthcare. Needle-related procedures such as venipuncture and intravenous (IV) cannulation are among the most frequent sources of acute pain for children, and inadequately treated pain can have lasting physiological and psychological consequences. Stevens highlights that pain in children is a multidimensional experience involving emotional, cognitive, and behavioral domains, highlighting the need for comprehensive management strategies [1]. Despite this, pediatric pain is frequently underestimated and undertreated, as emphasized by the American Academy of Pediatrics (AAP), which calls for structured pain assessment and timely analgesic interventions for infants and children undergoing invasive procedures [2].

Topical anesthetics such as the Eutectic Mixture of Local Anesthetics (EMLA) cream have been widely used to reduce procedural pain. Evidence from several clinical studies and reviews indicates that EMLA effectively decreases discomfort associated with venipuncture and IV catheter placement in pediatric patients [3–5]. Its analgesic effect and safety profile make it a standard option in many pediatric units. However, EMLA requires 45–60 minutes to achieve sufficient dermal anesthesia, and its availability and cost can limit use in high-volume or resource-constrained settings typical of low- and middle-income countries (LMICs). These limitations highlight the need for practical, rapidly deployable alternatives.

Digital Distraction (DD) represents a non-pharmacological alternative grounded in attentional control theory, which posits that directing cognitive resources toward immersive visual and auditory stimuli reduces the perceptual salience of painful input. Age-appropriate animated videos act by capturing and sustaining the child’s attentional bandwidth, thereby modulating pain interpretation at the cortical level. Prior studies demonstrate that distraction reduces both perceived pain and distress in children undergoing medical procedures such as laceration repair and immunization [6–12]. Digital technology–based distraction has shown encouraging results; a recent meta-analysis reported that digital tools significantly reduce acute procedural pain in children, supporting their role in modern pediatric pain protocols [13].

Nonetheless, key gaps remain. First, although both EMLA and Digital Distraction (DD) have shown individual efficacy, direct head-to-head comparisons within the same pediatric population are scarce, especially in LMIC settings where decisions must consider feasibility, cost, and time constraints. Second, prior studies often differ in methodology, content used for distraction, and pain assessment strategies, making cross-study comparisons challenging. Third, as highlighted by previous authors, the subjective nature of pain scoring introduces potential inter- and intra-observer variability, necessitating careful design to minimize bias [14–16].

Despite evidence supporting both modalities independently, direct comparative data between EMLA and standardized Digital Distraction during pediatric IV cannulation are limited, particularly in the Indian context. Many distraction studies also use heterogeneous content, making comparisons difficult. Given known inter-individual variability in pain perception and coping styles among children, a crossover design—in which each child receives both interventions—allows for more precise within-subject comparison by minimizing baseline variability.

Given these considerations, the present study was conducted to address the lack of direct comparative evidence between EMLA cream and DD in pediatric IV cannulation. The primary objective was to compare procedural pain at 0, 1 and 3 minutes post-cannulation using the Wong–Baker FACES Pain Rating Scale (WBFPS) among children aged 5–12 years who experienced both interventions in a quasi-experimental crossover design. In accordance with attentional and pharmacologic mechanistic principles, we established a 1-point non-inferiority margin to evaluate whether Digital Distraction could match the analgesic performance of EMLA.

By comparing a pharmacologic analgesic with a feasible digital distraction strategy within the same cohort of children, this study aims to provide practical, contextually relevant evidence for improving pediatric procedural pain management in resource-limited clinical environments.

This quasi-experimental, non-randomized crossover trial was conducted over a period of one year in the Department of Pediatrics at a tertiary care teaching hospital in Northern India and reported in accordance with the TREND guidelines [17]. The study evaluated whether Digital Distraction (DD) was non-inferior to EMLA cream in reducing procedural pain during intravenous (IV) cannulation in children aged 5–12 years. Ethical clearance was obtained from the Institutional Ethics Committee (IEC No. RC-791-22-06-2023).

The sample size was determined a priori using a non-inferiority framework. Calculations were based on data from Yıldırım et al. (2013), who compared virtual reality (VR) distraction with standard care in children undergoing painful procedures [16]. In that study, the VR distraction group had a mean WBFPS score of 5.6 ± 1.9, while the control group had a mean of 6.2 ± 1.0. Using a two-sided alpha of 0.05, 90% power, an allocation ratio of 1:1, and a clinically meaningful non-inferiority margin of 10% (equivalent to 0.6 points on the WBFPS scale), the minimum required sample size was 68 children per group (136 total). Accounting for 10% attrition, the final sample size target was 150, and 161 children completed both phases.

Assignment to receive EMLA first or digital distraction (DD) first was based on parental preference after a detailed explanation of both interventions. The study used a paired crossover design in which every child received both interventions during two separate cannulation attempts, allowing each participant to serve as their own control. Some children received EMLA before the first cannulation and DD during the second, while others received the reverse sequence. The second cannulation occurred later during the hospital stay, which helped control for individual variations in baseline pain tolerance and familiarity with the procedure.

EMLA cream, a eutectic mixture containing 2.5% lidocaine and 2.5% prilocaine, was applied at a dose of roughly 1 g per 10 cm², with a maximum of 2 g per site in accordance with pediatric FDA recommendations. Older children (7–12 years, weighing more than 20 kg) could receive up to 20 g over 200 cm² for up to four hours. The cream was applied 45–60 minutes before cannulation under an occlusive dressing, and the skin was examined on removal for erythema, edema, or other local reactions.

Digital distraction consisted of a standardized set of preloaded, offline animated cartoon videos selected for age appropriateness and visual engagement. These videos were shown beginning 10–15 minutes before cannulation, continued throughout the procedure, and extended for three minutes afterward. The device was positioned in the child’s direct line of sight, and adherence to the distraction protocol was ensured by a trained staff member or simulation technician.

Each child formed the unit of delivery and analysis, and interventions were administered individually with no cluster effects. Fidelity was maintained through preloaded uniform content, fixed viewing angles, and the absence of co-interventions.

The study aimed to compare procedural pain between EMLA and DD, evaluating whether DD was non-inferior to EMLA within a one-point margin on the Wong–Baker FACES Pain Rating Scale (WBFPS). Pain was assessed at 0, 1, and 3 minutes after cannulation by a trained independent assessor who was blinded to intervention identity through the use of coded, audio-free video recordings. Because the nature of the interventions made participant and clinician blinding impossible, outcome blinding was strictly preserved.

Pain scores were non-normally distributed based on Shapiro–Wilk testing. Paired differences between interventions at each time point were analyzed with the Wilcoxon signed-rank test. Prespecified subgroup analyses examined effects of prior painful experiences, cannulation site and cannula gauge. No imputation was required because all participants completed both phases. Analyses were performed using IBM SPSS version 21, with statistical significance set at p ≤ 0.05, and a predefined non-inferiority margin of 10% to represent a clinically meaningful difference in pain scores.

A total of 204 children were screened for eligibility, of whom 43 were excluded (27 did not meet inclusion criteria, 12 declined participation, and 4 were unable to complete the protocol for logistical reasons). The remaining 161 children were enrolled, provided assent/consent, and completed both intervention phases without loss to follow-up or protocol deviations. Of these, 68 children received EMLA first, and 93 received Digital Distraction first, in accordance with parental preference for the initial procedure. All participants subsequently crossed over to the alternate intervention at the second clinically indicated cannulation, resulting in paired data for all children (Fig. 1).

Recruitment occurred between July 2023 and June 2024. Baseline demographic and clinical characteristics are summarised in Table 1. The two initial sequence groups—those receiving EMLA first (Sequence A) and those receiving Digital Distraction first (Sequence B)—were comparable across all key variables, including age, sex distribution, prior venepuncture exposure, underlying comorbidities, cannulation site, and cannula gauge. As all enrolled children completed both intervention phases, no further comparisons between retained and lost participants were necessary.

No adverse effects or unintended events (e.g., erythema, edema, hypersensitivity) were observed in either intervention phase.

Paired comparisons demonstrated that EMLA consistently resulted in significantly lower pain scores than Digital Distraction at all measured timepoints. At 0 minutes, immediately after cannulation, both interventions showed an expected rise from baseline; however, the rise was significantly smaller under EMLA (Wilcoxon Z = − 10.567, p < 0.001) compared with DD (Z = − 11.36, p < 0.001). The median paired difference exceeded the predefined 1-point non-inferiority margin, indicating that DD was not non-inferior to EMLA at peak procedural pain.

At 1 minute, pain had begun to decline in both conditions, but remained significantly lower with EMLA (Z = − 7.576, p < 0.001) than with DD (Z = − 10.315, p < 0.001). By 3 minutes, pain continued to fall, with EMLA again demonstrating a more favorable trajectory (Z = − 1.126, p < 0.001) compared with DD (Z = − 6.588, p < 0.001). Across all intervals, the observed paired differences exceeded the non-inferiority limit, confirming that Digital Distraction was not non-inferior to EMLA for procedural analgesia.

Within each intervention, pain decreased significantly over time. The reduction from 0→1 minute and 0→3 minutes was significant in both groups, but the magnitude of decline was greater and more consistent with EMLA, indicating a more stable analgesic effect (Table 2, Fig. 2).

Subgroup Analyses

Children with and without prior painful procedures showed similar patterns: EMLA consistently produced lower pain scores across all time points. Prior procedural exposure did not significantly modify the comparative effectiveness (Table 3A).

Pain tended to be higher with larger-gauge cannulas (20G > 22G > 24G). Across all gauge sizes, EMLA continued to yield more favorable pain profiles. Significant differences were observed particularly for 20-gauge cannulations, where EMLA demonstrated considerably superior analgesia (Table 3C).

This quasi-experimental crossover study compared the effectiveness of Digital Distraction (DD) and EMLA cream in reducing procedural pain during intravenous cannulation among children aged 5–12 years. The findings demonstrate that EMLA provided consistently superior pain relief across all measured intervals, while DD offered partial but insufficient analgesia to meet the predefined non-inferiority criterion. These findings are consistent with the proposed mechanisms of the interventions: EMLA exerts a pharmacologic dermal anesthetic effect, reducing nociceptive afferent signals at the site of needle insertion, whereas Digital Distraction relies on attentional shift—redirecting cognitive resources away from the painful stimulus through visual and auditory engagement. Although DD successfully lowered pain relative to baseline, it did not adequately attenuate the peak nociceptive response, which is better addressed by a pharmacological agent.

The superiority of EMLA observed in this study is well supported by existing literature. Cordoni and Cordoni reported significant reductions in cannulation pain with EMLA [4], while Shrinivas and Kumar similarly demonstrated that topical anesthesia provides superior dermal analgesia compared with placebo [5]. Young et al. observed that EMLA applied before phlebotomy significantly improved pain tolerance [15], and Robieux et al. highlighted its clear benefit in reducing pain perception in pediatric venipuncture [18]. These previous findings confirm that EMLA reliably minimizes nociceptive input during needle procedures and directly align with the pain trajectories observed in our population.

Digital distraction, although not non-inferior to EMLA, did reduce the rise in pain from baseline and showed a consistent downward trend in pain scores over time. This aligns with prior evidence demonstrating partial analgesic benefit with distraction. Sinha et al. found that distraction reduced distress during laceration repair [7], and Shahid et al. showed that distraction through iPads lowered pain during immunization [9]. Rao et al. similarly reported reductions in pain with virtual reality distraction [10]. These findings collectively support the role of DD as a helpful adjunctive modality based on attentional diversion. Furthermore, earlier work investigating distraction techniques has shown that while they can reduce distress and perceived discomfort, their effectiveness varies depending on the child’s engagement, the intensity of the painful stimulus, and the distraction content. Our standardized DD protocol minimized variability in content—a limitation often noted in distraction studies—yet the analgesic effect remained modest compared with EMLA. The attentional control theory underlying distraction posits that competing sensory input reduces cognitive capacity available for pain processing; however, during high-intensity, rapid-onset stimuli such as needle insertion, the efficacy of distraction appears limited. The work of Gates et al., which found significant variability in distraction-related analgesia across studies, further contextualizes why DD did not achieve non-inferiority [13].

The temporal profile of pain in this study also reinforces known physiological mechanisms. Pain peaked immediately after insertion for both interventions, reflecting the sharp nociceptive impact of skin penetration. However, pain declined more rapidly and consistently in the EMLA phase, demonstrating the sustained dermal blockade provided by the anesthetic mixture. This pattern is consistent with previous findings indicating that distraction is less effective when pain is intense or perceived as threatening, as highlighted by Van Damme et al. [6].

An important strength of this study is its crossover design, which allowed each child to serve as their own control. This reduces potential confounding arising from inter-individual differences in pain threshold, prior medical experiences, temperament, and coping strategies—factors that are especially relevant in pediatric behavioral research. The use of a blinded independent assessor reviewing video-recorded facial expressions further minimized observer bias. Additionally, the standardized distraction content and consistent procedural workflow improved fidelity and ensured that differences in performance were attributable to the interventions rather than contextual inconsistencies.

Subgroup analyses reinforced the overall findings. EMLA maintained superior analgesia across cannulation sites, cannula gauges, and among children with or without previous painful medical experiences. Even in inherently more painful scenarios — such as dorsal hand cannulations or use of larger-gauge cannulas — EMLA demonstrated better pain control, proving its reliability across procedural contexts. These observations are consistent with earlier literature demonstrating the reproducibility of EMLA’s analgesic effects across varied clinical situations [3, 19–21].

Despite these strengths, several potential sources of bias must be considered. First, the study employed non-randomized allocation based on parental preference, introducing the possibility of selection bias. Although the paired crossover design mitigated this risk, the initial assignment could still reflect parental expectations or child temperament. Second, participants and intervention deliverers were not blinded due to practical constraints inherent to behavioral and topical interventions. Third, as with all self-report pain scales, subjective interpretation remains a limitation despite using a validated tool and blinded scoring. Fourth, the absence of a formal washout period between interventions could theoretically result in carryover effects, although the natural clinical spacing between cannulations likely minimized this risk. Finally, the distraction effect may vary depending on the individual child’s preferences, interest level, or familiarity with digital media; while standardized content reduces variability, it cannot eliminate individual differences in engagement.

Implementation fidelity was high, but practical barriers observed during workflow—such as maintaining device placement within the child’s line of sight or ensuring continuous engagement—highlight the challenges of integrating distraction consistently in dynamic clinical settings. In contrast, EMLA use requires preparation time and may not always be feasible in fast-paced emergency units. As noted by Gates et al., distraction techniques can be valuable in such environments when implemented consistently [13]. These contextual factors are important for interpreting real-world applicability.

The findings carry pragmatic implications for pediatric procedural pain management, particularly in resource-limited settings. While EMLA remains the superior analgesic, its cost, availability, and required application time may limit routine use in high-volume pediatric units. Digital Distraction, despite not meeting non-inferiority criteria, demonstrated meaningful pain reduction relative to baseline and remains an accessible, low-cost adjunct that can enhance the overall procedural experience, especially where topical anesthetics cannot be used. Given that distraction has broader benefits in reducing anxiety and improving cooperation, it may still serve as an important supportive measure alongside pharmacological analgesia.

Generalizability of these findings is strengthened by the pragmatic design, real-world clinical setting, and inclusion of a broad pediatric age range typical of cannulation scenarios. However, external validity may be influenced by local factors such as staff expertise, patient demographics, caregiver expectations, and availability of digital tools. Further studies could explore combined approaches—EMLA plus DD—and evaluate the additive benefits for child comfort and cooperation.

In conclusion, this study demonstrates that EMLA cream provides superior analgesia at all measured intervals during pediatric intravenous cannulation, while Digital Distraction offers modest but meaningful reductions in pain. DD did not achieve non-inferiority and should therefore be considered an adjunct rather than a substitute for topical anesthesia. In settings where EMLA application is not possible, Digital Distraction remains a valuable, accessible alternative capable of enhancing the child’s overall experience. The methodological rigor, crossover design, standardized distraction protocol, and blinded assessment contribute to the reliability of the findings. Together, these findings support a multimodal approach to optimizing pediatric procedural comfort, particularly in resource-limited environments where balancing feasibility and analgesic efficacy is essential.