Pediatric Delirium

University of Massachusetts, Worcester

Status and phase: Invitation-only; Phase 4

Conditions: Pediatric Delirium

Treatments: Drug: Oral Midazolam; Drug: Intra-nasal Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04669457

H00021788

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 months to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intra-nasal Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Intra-nasal Dexmedetomidine

Oral Midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Oral Midazolam