NCT02314546

Intranasal Midazolam in Children as a Pre-Operative Sedative

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bassett Healthcare · Academic / Other
• Sex: All
• Age: 18 Months – 7 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sedation, Conscious

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-12-11
• Last updated: 2015-07-23
• Results posted: 2015-07-23

Locations

1 site across 1 country: United States