Intranasal Midazolam in Children as a Pre-Operative Sedative

Bassett Healthcare15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sedation, Conscious

Interventions

MidazolamDRUG

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.

xylocaineDRUG

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 placeboDRUG

Placebo - Control patients will receive intranasal saline.

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Bassett Healthcare Network

Cooperstown, New York, United States

Outcomes

Primary Outcomes

Sedation Scale Score

Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

Time frame: 10 minutes post-sedation

Sedation Scale Score

Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

Time frame: 15 minutes post-sedation

Time From Administration to Discharge

Time frame: Minutes from administration to discharge

Secondary Outcomes

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).

Time frame: 1 minute post-administration

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).

Time frame: 1 minute post-administration

Verbal Complaint

Recorded by the administering RN at the time of administration.

Time frame: At time of administration

Verbal Complaints

Recorded by the administering RN at one minute post-administration

Time frame: 1 minute post-administration

Data from ClinicalTrials.gov

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