Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

June 30, 2008

Conditions
Basal Cell CarcinomaSquamous Cell CarcinomaSkin CancerAnxiety
Interventions
DRUG

Randomized Midazolam

Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup.

OTHER

Placebo

The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.

DRUG

Local Anesthesia

Lidocaine 1% with 1:100,000 epinephrine

DRUG

Prospective Midazolam

Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (\>45 to 77 kg, 10 mg; \>77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER