May 1998

Ropivacaine in paediatric surgery: preliminary results.
Ivani G, Mereto N, Lampugnani E, De Negri P, Torre M, Mattioli G, Jasonni V, Lonnqvist PA; Paediatric Anaesthesia 1998;8:127-130.
[ see abstract below ]

Ivani et al conducted a double blind study of bupivacaine (0.25%, 2 mg/kg) vs. ropivacaine (0.2%, 2 mg/kg) for caudal anesthesia and postoperative pain management in children. They found that ropivacaine was an effective local anesthetic in children and even suggested that, because of its apparent better cardiotoxic profile, it may offer a wider margin of safety for children.

I applaud their early investigations comparing ropivacaine with the standard bupivacaine. Bupivacaine never received FDA approval for children less than 12 years of age because the company never sponsored the appropriate studies to achieve pediatric labeling. Perhaps the manufacturer felt that the pediatric market was too small to justify the investment. Thus a drug that is used every day, even on preterms, still remains unlabelled for children!

Ropivacaine has recently been released and as usual there is little pediatric data, in fact the PDR states "No special studies were conducted in pediatrics. Until further experience is gained in children younger than 12 years, administration of Naropin in this age group is not recommended." Despite many requests from a variety of reputable pediatric anesthesiologists the manufacturer chose not to conduct pediatric studies until an open forum sponsored by the FDA forced the issue (studies are now ongoing). This lack of interest in pediatric studies by the manufacturer was an inexcusable omission in the drug approval process because these studies should have been carried out at the phase III level so that a pediatric label could have been developed prior to release.

Ivani and colleagues are to be commended for helping to collect a pediatric experience. However, before the pediatric community embraces this new local anesthetic, I feel it important to await the development of a wider scientific data base which will allow appropriate pediatric labeling and the development of appropriate dosing recommendations.*

* Note: Physicians should never deny a pediatric patient the benefit of a new drug simply because the drug is not "approved" for pediatric use. This would deny children access to about 80% of drugs available. However, good judgment, dosing based on published experience, and use of drug within the community allow physicians to use any drug in the patient's best interest. For further reading see also: Da Conceicao, MJ, Coelho, L: Caudal anaesthesia with 0.375% ropivacaine or 0.375% bupivacaine in paediatric patients. BJA 1998;80:507-508.

See related articles by Dr. Cote:
Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures

Washington Report

ASA Update for Pediatrics

Return to the Current Literature Review Front Page , or read the abstract:

ABSTRACT