Cooperstown, New York 13326


Purpose:

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


Criteria:

Inclusion Criteria: 1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat 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 Observed Behavioral Distress (OBD) Visual Assessment Scale (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:

NCT02356705


Primary Contact:

Principal Investigator
david Ullman, MD
Bassett Healthcare

jennifer victory, RN
Phone: 607-547-6965
Email: jennifer.victory@bassett.org


Backup Contact:

Email: catherine.gilmore@bassett.org
catherine gilmore, RN
Phone: 607-547-7926


Location Contact:

Cooperstown, New York 13326
United States

Jennifer Victory, RN
Phone: 607-547-6965
Email: jennifer.victory@bassett.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.