NCT02314546 - Intranasal Midazolam in Children as a Pre-Operative Sedative | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions

Sedation, Conscious

Interventions

DRUG

Midazolam

"Study participants will be randomly assigned to one of three treatment groups:~* Group 1 - Placebo - Control patients will receive intranasal saline.~* Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.~* Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam."

DRUG

xylocaine

Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.

DRUG

saline placebo

Placebo - Control patients will receive intranasal saline.

Trial Locations (1)

13326

Bassett Healthcare Network, Cooperstown