Stability of a novel Lidocaine, Adrenaline and Tetracaine sterile thermosensitive gel: A ready-to-use formulation.

Background: Superficial wounds that require suturing are often the reason children visit the Paediatric Emergency Department. Suturing is usually accompanied by perilesional administration of lidocaine, a local anaesthetic drug that improves pain tolerance. In paediatric patients, this approach has a low compliance because lidocaine has to be injected, which in children generates fear and anxiety, a sterile anaesthetic gel could improve the child compliance.

Objective: To develop a sterile and stable sterile gel capable of remaining in place over time for topical anaesthesia.

Method: Different formulations were analysed by HPLC, by UV and fluorimetric detection. Two different sterilisation methods were tested.

Main Outcome: To maintain the original stability of the gel also after sterilisation process.

Results: Four different gels were prepared and analysed; the most stable gel lasts over 3 months with a degradation less than 10%.

Conclusion: The use of Poloxamer 407 guarantees stability of the preparation, showing a reduction in oxidative reaction, and gives the gel the right texture for application to a bleeding wound.