Pediatric Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2026-04-05

Brief Summary

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

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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.

Conditions

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Pediatric Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.

Study Groups

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Intra-nasal Dexmedetomidine

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.

Group Type EXPERIMENTAL

Intra-nasal Dexmedetomidine

Intervention Type DRUG

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.

Oral Midazolam

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.

Group Type ACTIVE_COMPARATOR

Oral Midazolam

Intervention Type DRUG

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.

Interventions

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Intra-nasal Dexmedetomidine

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.

Intervention Type DRUG

Oral Midazolam

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.

Intervention Type DRUG

Other Intervention Names

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Precedex Midazolam

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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes