Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 7 |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| Contact: | jennifer victory, RN |
| Email: | jennifer.victory@bassett.org |
| Phone: | 607-547-6965 |
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
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
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
We found this trial at
1
site
Cooperstown, New York 13326
Principal Investigator: David ullman, MD
Phone: 607-547-6965
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