At a glance
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Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
In Brief
A Phase 4 clinical trial evaluating Midazolam, xylocaine, and 1 other intervention for Sedation. Completed, enrolled 42 participants across 1 site.
Detailed Summary
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
Study Details
Timeline
Interventions
midazolam 0.2 mg/kg given intranasally
intransal xylocaine given in conjunction with intranasal midazolam
intranasal saline given as placebo