NCT02356705

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Jennifer Victory, RN, CCRC · Academic / Other
• Sex: All
• Age: 18 Months – 7 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Midazolam	midazolam 0.2 mg/kg given intranasally
DRUG	xylocaine	intransal xylocaine given in conjunction with intranasal midazolam
DRUG	saline placebo	intranasal saline given as placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-02-05
• Last updated: 2022-03-16
• Results posted: 2021-02-25

Locations

1 site across 1 country: United States