D2.42 - Evaluation of User Experience with a Skin Prick Automated Test (SPAT) Device compared to a Manual Skin Prick Test (SPT) in Pediatric Patients

Skin prick testing (SPT) remains the diagnostic gold standard for identifying type I sensitizations. In pediatric patients, testing may be associated with pain and distress. This randomized controlled study compares an automated prick device (SPAT) with conventional manual SPT regarding patient comfort.

Of 160 planned children and adolescents aged 5–17 years in this prospective randomized study, 143 have been enrolled and 141 patients analyzed (SPAT n=73; SPT n=68). Two participants in the SPT group discontinued and were excluded, none discontinued in the SPAT group. Pain and discomfort were assessed after testing using the Wong-Baker FACES Pain Rating Scale (WBFPRS) and the FLACC (Face-Legs-Activity-Cry-Consolability) scale.

Age-stratified analysis (5–12 years: SPAT, n=45; SPT, n=49; 13‑17 years: SPAT, n=28; SPT, n=19) and group comparisons were performed using the Mann-Whitney U test.

No significant difference in pain scores was observed between SPAT and SPT. Interim analysis showed a clear trend toward lower pain perception in the SPAT group (WBFPRS: SPAT 2.0 [0.0–2.0] vs. SPT 2.0 [2.0–4.0]; p=0.070). FLACC scores were comparable between methods (FLACC: SPAT 2.0 [1.0–4.0] vs. SPT 2.0 [1.0–5.0]; p=0.441).

Age-stratified analysis showed a tendency for lower pain perception in the SPAT group in both age categories, although statistical significance has not yet been reached (WBFPRS: 5–12 years, SPAT 2.0 [0.0–4.0] vs. SPT 2.0 [2.0–4.0]; p=0.381; 13-17 years, SPAT 2.0 [0.0–2.0] vs. SPT 2.0 [2.0–2.0]; p=0.098). Pain and discomfort were generally higher in younger children. Discomfort analysis between SPAT and SPT showed no significant difference in either age group (FLACC: 5-12 years, SPAT 2.0 [1.0–5.0] vs. SPT 3.0 [1.0–6.0]; p=0.234; 13-17 years, SPAT 1.0 [1.0–2.0] vs. SPT 1.0 [0.0–2.0]; p=0.191), based on external observation rather than self-assessment. No procedural discontinuations occurred in the SPAT group, whereas two occurred in the SPT group.

These interim results suggest that SPAT allows allergological testing in children with comparable or even lower pain perception than conventional SPT, though statistical significance was not yet reached. The absence of discontinuations in the SPAT group may indicate improved procedural feasibility and tolerability. Final analysis with the completed cohort will be required to confirm these findings and their impact on pediatric patient comfort during skin prick testing.