Intranasal Midazolam in Children as a Pre-Operative Sedative

Sedation, Conscious Clinical Trial

Official title:

Intranasal Midazolam in Children as a Pre-Operative Sedative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314546
• Other study ID #: 994
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2014
• Last updated: June 25, 2015
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: June 2015
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation, Conscious

Intervention

Drug:
• Midazolam
Study participants will be randomly assigned to one of three treatment groups: Group 1 - Placebo - Control patients will receive intranasal saline. Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam. Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
• xylocaine
Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
• saline placebo
Placebo - Control patients will receive intranasal saline.

Locations

Country	Name	City	State
United States	Bassett Healthcare Network	Cooperstown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bassett Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation Scale Score	Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.	10 minutes post-sedation	No
Primary	Sedation Scale Score	Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.	15 minutes post-sedation	No
Primary	Time From Administration to Discharge		Minutes from administration to discharge	No
Secondary	Parental Observed Behavioral Distress Score	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).	1 minute post-administration	No
Secondary	RN Observed Behavioral Distress Score	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).	1 minute post-administration	No
Secondary	Verbal Complaint	Recorded by the administering RN at the time of administration.	At time of administration	No
Secondary	Verbal Complaints	Recorded by the administering RN at one minute post-administration	1 minute post-administration	No