'Kiddie Caudal' Anesthesia Seems Safe But More Research Needed
In their accompanying editorial, Drs Boretsky and DiNardo raise some methodological concerns—particularly related to the use of the PRAN data. Like other large databases, PRAN lacks many key details on the patients' characteristics and the treatments they receive. That makes it difficult to evaluate some of the variations observed in the study, and to determine the true safety of the caudal nerve block procedure.
For example, the study found significant variations in local anesthetic dose. Dr Suresh and coauthors suggest that about one-fourth of children receiving "potentially toxic" doses—particularly younger children.
But the variations in dose may be related to other factors, such as differences in the surgical procedures performed, according to Drs Boretsky and DiNardo. They write, "[A]lthough it is true that proportionally higher doses were given in younger patients, the reason and significance of this finding are unclear."
In addition, Drs Boretsky and DiNardo question the study's definition of "potentially unsafe doses." They note that the only two children with systemic (generalized) toxic effects received doses well within standard guidelines. They also point out issues related to unexplained variations in dosing with different anesthetics (ropivacaine versus bupivacaine) and the detection block failure—the most common complication.
Studies using large databases such as PRAN are valuable. By combining data from many different hospitals, they can detect infrequent complications and adverse effects that may not occur in smaller studies. But such studies may also be "overpowered," introducing certain types of statistical errors. Very large database studies may find differences that are "statistically significant," but too small to be clinically significant. Continue>
Posted in: Procedures | August 6, 2013