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Clinical Studies

14 CLINICAL STUDIES

Ketamine Hydrochloride Injection has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients in 105 separate studies. During the course of these studies, Ketamine Hydrochloride Injection was administered as the sole general anesthetic, as an induction agent prior to administration of other general anesthetics, or to supplement other anesthetic agents.

Ketamine Hydrochloride Injection has been evaluated during the following procedures:

1.
debridement, dressing changes, and skin grafting in burn patients, as well as other superficial surgical procedures.
2.
neurodiagnostic procedures such as myelograms and lumbar punctures.
3.
diagnostic and operative procedures of the ear, nose, and mouth, including dental extractions.
4.
sigmoidoscopy and minor surgery of the anus and rectum, and circumcision.
5.
extraperitoneal procedures, such as dilatation and curettage.
6.
orthopedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies.
7.
cardiac catheterization procedures.
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