Intranasal Midazolam in Children as a Pre-Operative Sedative

Completed · Phase 4 · Has a placebo group

Conditions studied: Sedation, Conscious

In brief

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.

Key facts

Study ID

NCT02314546

Run by

Bassett Healthcare

People needed

15

Starts

2011-12-01

Expected to finish

2014-01-01

Last updated by the study team

2015-07-23

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia
• American Society of Anesthesiologists (ASA) Class 1 or 2
• Parent willing and able to provide written informed consent
• Parent willing and able to complete the OBD VAS

You may not qualify if…

• ASA Class 3 or greater
• History of allergy to midazolam or xylocaine
• Presence of acute respiratory infection at time of surgery
• Parent unwilling or unable to provide informed consent
• Parent unwilling or unable to complete the OBD VAS

Where it is running

• Bassett Healthcare Network — Cooperstown, New York, United States

Full record on ClinicalTrials.gov

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