Pediatric Delirium

Phase 4Enrolling By InvitationNCT04669457

University of Massachusetts, Worcester60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Pediatric Delirium

Interventions

Intra-nasal DexmedetomidineDRUG

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 MidazolamDRUG

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.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Time to onset of pediatric delirium

Time from when the patient is woken from anesthesia to the onset of delirium.

Time frame: Zero minutes to 48 hours

Time to offset of pediatric delirium

Time from onset of delirium to the offset of delirium.

Time frame: Zero minutes to 48 hours

Duration of pediatric delirium

Total time patient experiences delirium

Time frame: Zero minutes to 48 hours

Secondary Outcomes

Drug Acceptance

The willingness of the subject to take the drug was assessed in the pre-operative area

Time frame: 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.

Time frame: 0-48 hours

Mask Acceptance Scale

The child's acceptance of the mask by the anesthesiologist was rated as follows.

Time frame: 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.

Time frame: 0-12 hours

Rescue analgesia in PACU

The amount and dose of oral/rectal acetaminophen given in PACU was recorded.

Data from ClinicalTrials.gov

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