Compounded LAT Gel for Pediatric Laceration Repair: Strengthening Endpoints,Safety Reporting,and Beyond-Use Dating

Dear Editor,

Favia et al report an in-hospital compounded, sterile, thermosensitive LAT gel (lidocaine 4%-adrenaline 0.05%-tetracaine 0.5%) prepared under Grade A/Grade B conditions, with HPLC-confirmed maintenance of lidocaine, tetracaine, and adrenaline content during refrigerated storage (2 °C-8 °C) for up to 120 days. They evaluate clinical use in 83 children and report that 83.1% (69/83) required no additional anesthesia; the 16.9% (14/83) requiring escalation were mainly those with deep/extensive lacerations. ¹

These real-world outcomes are broadly consistent with prior clinical evidence supporting topical LAT as a needle-sparing option for laceration repair, including randomized prospective comparisons versus injectable buffered lidocaine assessing application/injection pain and anesthesia effectiveness. ² However, LAT gel remains underused in the repair of pediatric lacerations. ³ In this light, the current work is particularly valuable because it couples ED implementation with a structured pharmacy compounding workflow and a defined stability program.

Several aspects could further strengthen interpretation and portability. First, the pragmatic endpoint (“no need for additional anesthetic methods”) is clinically meaningful but may be influenced by clinician thresholds, wound characteristics, procedural complexity, and patient distress; adding standardized pain and anxiety measures (at baseline, after application, and during closure), time-to-readiness (they report ~30 minutes to effect), and short follow-up outcomes (infection, healing, cosmesis) would improve comparability across sites. Second, while the authors discuss limitations of prior lidocaine-prilocaine cream for injured skin, they also note that the cream was still used in 11% of cases during monitoring; a prospective comparator approach (or a pre-specified stepped-wedge/controlled implementation) and wound-stratified reporting (depth/length/location) would better quantify the incremental benefit of LAT and define optimal case selection.

Safety and “in-use” performance deserve explicit emphasis for a preservative-free, vasoconstrictor-containing product applied to open wounds. Although escalation patterns are reported (lidocaine infiltration 57.2% [8/14], oral midazolam 28.6% [4/14], intranasal midazolam 7.1% [1/14], fentanyl 7.1% [1/14]), broader adoption would be supported by structured adverse-event reporting (local ischemic changes, dermatitis, delayed healing, infection, and systemic toxicity signals) and clear guidance on anatomic/site exclusions and monitoring. Finally, while the 120-day chemical stability data are a strength, the noted analytical challenge (low-signal adrenaline peak) and ED workflow realities argue for stability-indicating validation detail and “in-use” simulations (light exposure, temperature excursions, repeated access, container-closure interactions) when proposing operational beyond-use dating; the stability-indicating approach used in other Hospital Pharmacy compounding studies provides a practical template for such reporting. ⁴

Going forward, the field would benefit most from multicenter prospective studies comparing LAT gel with standard infiltrative anesthesia and/or topical comparators, using standardized patient-centered outcomes and workflow metrics, predefined wound-stratification (to clarify when LAT alone is sufficient versus when escalation should be anticipated), and harmonized safety surveillance. Parallel pharmacy studies should expand beyond strength-at-timepoints toward stability-indicating and “in-use” testing that directly supports robust beyond-use dating and implementation across emergency settings.