Pediatric Delirium

Study Overview
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Brief Summary
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Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.

Detailed Description
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Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.

Official Title
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Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.

Conditions
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Pediatric Delirium

Intervention / Treatment
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* Drug: Intra-nasal Dexmedetomidine
* Drug: Oral Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 3 months to 9 years Scheduled to undergo a myringotomy American Society of Anesthesiologists (ASA) classification of I - II. Exclusion Criteria: Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease. Anyone age 10 years or older. Anyone with an ASA classification of III or higher. Non-English language speaker for whom short form consent is not available.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-nasal Dexmedetomidine<br>Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. | Drug: Intra-nasal Dexmedetomidine<br>* Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.<br>* Other names: Precedex;|
| Active Comparator: Oral Midazolam<br>Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. | Drug: Oral Midazolam<br>* Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.<br>* Other names: Midazolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of pediatric delirium | Time from when the patient is woken from anesthesia to the onset of delirium. | Zero minutes to 48 hours | 
| Time to offset of pediatric delirium | Time from onset of delirium to the offset of delirium. | Zero minutes to 48 hours | 
| Duration of pediatric delirium | Total time patient experiences delirium | Zero minutes to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Acceptance | The willingness of the subject to take the drug was assessed in the pre-operative area | 10-25 minutes prior to surgery | 
| Parental Separation Anxiety Scale (PSAS) | Anxiety score was determined when the child was separated from the parents according to four levels. | 0-48 hours | 
| Mask Acceptance Scale | The child's acceptance of the mask by the anesthesiologist was rated as follows. | 1-10 minutes prior to surgery | 
| End tidal Sevoflurane value | During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented. | 0-12 hours | 
| Rescue analgesia in PACU | The amount and dose of oral/rectal acetaminophen given in PACU was recorded. | 0-6 hours post surgery | 
| Home Behavior Analysis | The child's parents were given a diary to document their behavior for 48 hours post-operatively at home. | 12-48 hours | 
| Oral analgesic use | Document intake of oral analgesics like acetaminophen or ibuprofen | Two days post-operative |