Therapeutic properties and tolerance of procaine and phenazone containing ear drops in infants and very young children.

Unlabelled: Since ear pain is often intolerable in very young children with acute otitis media (AOM), a safe pain reduction is indispensable both from the medical as well as from the ethical point of view.

Methods: To confirm the safety and therapeutic properties of ear drops (Otalgan) consisting of the short acting local anesthetic procaine hydrochloride (CAS 51-05-8) and the anti-inflammatory component phenazone (CAS 60-80-0), a multi-center, non-interventional post marketing surveillance (PMS) study was performed in 428 children (f/m: 45.6%/ 54.