Assessing Local Reactions and Serum Enzyme Changes from Intramuscular Injections. A Preliminary Evaluation

¹ Departments of Infectious Diseases Research and Clinical Research Laboratory, The Upjohn Company, Kalamazoo, Michigan 49001.

Critical factors in measuring subjective discomfort and clinical signs of local reactions following I.M. injection of drugs include (1) standardization of the study environment, injection technique, and observations, (2) choice of discriminating variables, and (3) double-blind study conditions. Variables found helpful in evaluating injectable antibiotics were repeated subjective pain reports and physician evaluation of tenderness, swelling, and induration at the injection site. In comparing the test drug with standard drugs, within-subject comparisons were used in a sequential study with preference as the critical variable. In two-week multiple-dose between-subject comparisons, tenderness was the most discriminating variable. I.M. injections of mildly to moderately irritating drugs may affect SGOT and CPK values throughout the treatment course and for at least two days after the last dose, and this should be considered in using these enzyme levels as diagnostic aids. Elevations in serum CPK caused by I.M. injections of drugs may serve as an indicator of musculoirritancy, corroborating other data. However, serum CPK is sensitive to numerous factors and in our studies, even under clinic ward conditions, showed so much between-subject variability that it was less discriminating than clinical evaluations of local reactions in comparisons of I.M. treatments.

Note:

We acknowledge the contributions of E. Novak, M.D., in designing the early local tolerance studies of parenteral clindamycin preparations; M. H. Maile, M.S., and C. M. Metzler, Ph.D., in performing statistical analyses and providing helpful discussions; the staff of Jackson Experimental Clinic, State Prison of Southern Michigan, Jackson, Michigan, in supervising studies; and the inmates who served as volunteers.

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