Intranasal Midazolam in Children as a Pre-Operative Sedative

Phase 4

Completed

• Conditions: Sedation, Conscious
• Interventions: Drug: saline placebo; Drug: Midazolam; Drug: xylocaine

• Registration Number: NCT02314546
• Lead Sponsor: Bassett Healthcare

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-11
• Results First Submitted: 2015-01-28
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Results First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline placebo	saline placebo	saline placebo
Midazolam and Xylocaine	xylocaine	Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam
Midazolam and Xylocaine	Midazolam	Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam
Nasal Midazolam only	Midazolam	Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam

Primary Outcome Measures

Name	Time	Method
Sedation Scale Score	15 minutes post-sedation	Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time From Administration to Discharge	Minutes from administration to discharge

Secondary Outcome Measures

Name	Time	Method
Parental Observed Behavioral Distress Score	1 minute post-administration	Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
RN Observed Behavioral Distress Score	1 minute post-administration	Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Verbal Complaint	At time of administration	Recorded by the administering RN at the time of administration.
Verbal Complaints	1 minute post-administration	Recorded by the administering RN at one minute post-administration

Trial Locations

Locations (1)

Bassett Healthcare Network; 🇺🇸 Cooperstown, New York, United States