Pediatric Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intra-nasal Dexmedetomidine, Oral Midazolam.
- Who it may be relevant to
- Registry conditions: Pediatric Delirium. Basic parameters: 3 months — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- Time to onset of pediatric delirium [Time frame: Zero minutes to 48 hours]
- Time to offset of pediatric delirium [Time frame: Zero minutes to 48 hours]
- Duration of pediatric delirium [Time frame: Zero minutes to 48 hours]
Secondary outcome measures (7)
- Drug Acceptance [Time frame: 10-25 minutes prior to surgery]
- Parental Separation Anxiety Scale (PSAS) [Time frame: 0-48 hours]
- Mask Acceptance Scale [Time frame: 1-10 minutes prior to surgery]
- End tidal Sevoflurane value [Time frame: 0-12 hours]
- Rescue analgesia in PACU [Time frame: 0-6 hours post surgery]
- Home Behavior Analysis [Time frame: 12-48 hours]
- Oral analgesic use [Time frame: Two days post-operative]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Massachusetts Medical School — Worcester
Identifiers
NCT: NCT04669457 · H00021788