LAT Gel: from the Galenical Laboratory to the Paediatric Emergency Room - A Fondazione Policlinico Gemelli IRCCS Experience.

Abstract

Objectives: Lacerations are one of the most widespread and common emergencies among children, addressed by doctors in emergency room admissions. The aim of this study was to optimize the formulation of a pre-existing anaesthetic gel known as LAT gel (Lidocaine 4%, Adrenaline 0.05%, Tetracaine 0.5% gel), in order to allow the paediatric emergency department of the Policlinico A. Gemelli (Rome) to improve the management of lacerations, while avoiding the mandatory use of infiltrative anaesthesia. The aim of the study was also to assess the stability over time of the active ingredients (lidocaine, adrenaline, tetracaina) in the galenic preparation. Methods: LAT gel is a formulation prepared using: a poloxamer, Lutrol F127 (or Kolliphor P407), two anaesthetics (lidocaine and tetracaine), together with adrenaline. The formulation was prepared in a Grade A laminar flow hood and in a Grade B environment for microbial load. Batches were subjected to microbiological analysis by hospital hygiene as indicated in FU XII ("Official Italian pharmacopoeia XII edition"). The chemical stability of the gel was assessed by high-performance liquid chromatography. Results: Analysis showed that the lidocaine, tetracaine and adrenaline content in the LAT gel remained constant when stored in a refrigerator at 2 to 8°C for up to 120 days. The non-need for additional anaesthetic methods was considered as a parameter of effectiveness. 83 children were evaluated. In the cases recorded, 83.1% (69/83) of patients did not require an additional anaesthesia. Patients who required additional anaesthesia 16.9% (14/83) were those with deep and extensive lacerations. The results show that an effective, sterile, stable preparation with excellent applicability was prepared. Conclusion: This product lends itself to application to the wound surface with a better anaesthetic and haemostatic effect and, unlike injectable lidocaine, is an optimal treatment for increasing compliance in paediatric emergency rooms.