Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
The main objective of this study was to establish the safety and efficacy of midazolam in
patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were
randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for
efficacy in producing safe anxiolysis of short duration. A parallel prospective arm of the
study involved administration of midazolam in an unblinded fashion. Based on available
studies of orally administered midazolam, the expectation was that the only observed adverse
events will be minor and the major adverse event rate for midazolam would be similar to
placebo. Data was collected on vital signs, anxiety, adverse events, and overall
satisfaction with the anxiolytic agent.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Patient Anxiety at Baseline
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
Baseline (prior to drug administration)
Clark C Otley, MD
United States: Institutional Review Board
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