75
Participants
Start Date
March 31, 2007
Primary Completion Date
April 30, 2008
Study Completion Date
June 30, 2008
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.
Placebo
The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
Local Anesthesia
Lidocaine 1% with 1:100,000 epinephrine
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.
Mayo Clinic, Rochester
Lead Sponsor
Mayo Clinic
OTHER