Clinical trial NCT04669457: Pediatric Delirium
Official title: Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Pediatric Delirium
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to onset of pediatric delirium
timeFrame: Zero minutes to 48 hours
measure: Time to offset of pediatric delirium
timeFrame: Zero minutes to 48 hours
measure: Duration of pediatric delirium
timeFrame: Zero minutes to 48 hours
Secondary outcomes:
measure: Drug Acceptance
timeFrame: 10-25 minutes prior to surgery
measure: Parental Separation Anxiety Scale (PSAS)
timeFrame: 0-48 hours
measure: Mask Acceptance Scale
timeFrame: 1-10 minutes prior to surgery
measure: End tidal Sevoflurane value
timeFrame: 0-12 hours
measure: Rescue analgesia in PACU
timeFrame: 0-6 hours post surgery
measure: Home Behavior Analysis
timeFrame: 12-48 hours
measure: Oral analgesic use
timeFrame: Two days post-operative
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: R. Ian Richmond, MD
role: PRINCIPAL_INVESTIGATOR
References: