Expired Study
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Cooperstown, New York 13326


Purpose:

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.


Study 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.


Criteria:

Inclusion Criteria: 1. Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia 2. American Society of Anesthesiologists (ASA) Class 1 or 2 3. Parent willing and able to provide written informed consent 4. Parent willing and able to complete the OBD VAS Exclusion Criteria: 1. ASA Class 3 or greater 2. History of allergy to midazolam or xylocaine 3. Presence of acute respiratory infection at time of surgery 4. Parent unwilling or unable to provide informed consent 5. Parent unwilling or unable to complete the OBD VAS


NCT ID:

NCT02314546


Primary Contact:

Principal Investigator
david Ullman, MD
Bassett Healthcare


Backup Contact:

N/A


Location Contact:

Cooperstown, New York 13326
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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