Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Study Overview
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Brief Summary
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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. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration

Official Title
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Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Conditions
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Sedation

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 Ear/Nose/Throat 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 Observed Behavioral Distress (OBD) Visual Assessment Scale (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>Control patients will receive intranasal saline | Drug: saline placebo<br>* intranasal saline given as placebo<br>|
| Active Comparator: Nasal Midazolam Only<br>Patients will receive 0.2 mg/kg of intranasal midazolam | Drug: Midazolam<br>* midazolam 0.2 mg/kg given intranasally<br>|
| Active Comparator: Midazolam Plus Xylocaine<br>Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. | Drug: Midazolam<br>* midazolam 0.2 mg/kg given intranasally<br>Drug: xylocaine<br>* intransal xylocaine given in conjunction with intranasal midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement 1. Agitated: Previous criteria and/or refuses mask. (worst score) 2. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. 3. Calm: Previous criteria and accepts mask. 4. Drowsy: Previous criteria and accepts mask. 5. Asleep: Previous criteria and accepts mask. (best score) | 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia 1. Agitated: Patient clinging to parents and/or crying (worst score) 2. Alert: Patient is aware but not clinging to parent, may whimper but not cry. 3. Calm: Sitting or lying comfortably with spontaneous eye opening. 4. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation. 5. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score) | 20 minutes |