In Reply:—Three of the four citations referred to by Rose and Martin are abstracts. [1–3] as is the one we authored. [4] We did not believe that work published in abstract form qualified as proper studies in that the peer review process associated with their publication is much less thorough and the validity of the conclusions of a very tentative nature. The editorial staff of ANESTHESIOLOGY appear to agree, as the Guide for Authors for ANESTHESIOLOGY states that “abstracts are acceptable as references only if published within the previous 3 yr in an indexed journal.”[4] The remaining reference was published in March 1994. [5] Our original manuscript was submitted in 1993, and the final revision was submitted in March 1994. If we had been aware of this article, we would have rephrased that sentence.
With regard to the dose of metoclopramide used, we indeed stated in a previous article that “we were reluctant to increase the dose because of the potential for extrapyramidal effects.”[6] However, that referred to the dose we chose for that study and certainly points out the fact that we care about the well-being of our study patients. The patients had no dystonic reactions at the dose of 0.25 mg/kg, and as stated in the same article. “Although the benefit observed was not statistically significant at the lower dose studied (0.15 mg/kg), it became so at the higher dose (0.25 mg/kg), suggesting a dose- response relationship. Whether higher doses will prove more efficacious remains to be determined….”[6] We believed that, for the best chance for metoclopramide to be effective, it was worth administering a higher dose and monitoring for side effects, which, in the unlikely event that they occurred in a significant number, could have led to a reevaluation of the protocol. No episodes of extrapyramidal effects occurred. We were prepared to use the dose of 1 mg/kg diphenhydramine that the nurses administer routinely for patients who are experiencing extrapyramidal effects. (In our hospital, these events usually are associated with droperidol administration ordered by the surgical house staff.)
Although Grunberg and Hesketh [7] administered other drugs in combination with metoclopramide in their protocol, at least one other study used doses as high as 5 mg/kg without the routine administration of diphenhydramine. [8] In that study of 133 patients, the incidence of extrapyramidal effects was 2.2%, an acceptable number in view of the fact that our dose was an order of magnitude less. In another study, [9] bolus doses of 2 mg/kg metoclopramide up to a total of 10 mg/kg were given over an 8.5 h period. One of the 41 patients (2.4%) in that trial had extrapyramidal effects requiring treatment.
The parents of our patients were fully informed. The dose and risk of side effects were reviewed thoroughly by our institutional review board, which is chaired by a pediatric pharmacologist.
Alexander Rodarte, M.D., Assistant Clinical Professor.
Sheldon R. Furst, M.D., Instructor, Department of Anesthesia and Critical Care, Children's Hospital and Health Center and University of California, San Diego, Anesthesia Service Medical Group, P. O. Box 82807, San Diego, California 92138–2807.
(Accepted for publication February 10, 1995.)
*ANESTHESIOLOGY 81:43A-44A, 1994.