Intranasal Midazolam in Children as a Pre-Operative Sedative

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intranasal Midazolam in Children as a Pre-Operative Sedative

Conditions
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Sedation, Conscious

Intervention / Treatment
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* Drug: Midazolam
* Drug: xylocaine
* Drug: saline placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline placebo<br>saline placebo | Drug: saline placebo<br>* Placebo - Control patients will receive intranasal saline.<br>|
| Active Comparator: Nasal Midazolam only<br>Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam | Drug: Midazolam<br>* 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.<br>* Other names: versed;|
| Active Comparator: Midazolam and Xylocaine<br>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 | Drug: Midazolam<br>* 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.<br>* Other names: versed;Drug: xylocaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | 10 minutes post-sedation | 
| Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | 15 minutes post-sedation | 
| Time From Administration to Discharge |  | Minutes from administration to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Verbal Complaint | Recorded by the administering RN at the time of administration. | At time of administration | 
| Verbal Complaints | Recorded by the administering RN at one minute post-administration | 1 minute post-administration |