Pediatric Delirium

  • End date
    Aug 30, 2023
  • participants needed
  • sponsor
    University of Massachusetts, Worcester
Updated on 15 June 2022
Accepts healthy volunteers


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.

Condition Pediatric Delirium
Treatment oral midazolam, Intra-nasal Dexmedetomidine
Clinical Study IdentifierNCT04669457
SponsorUniversity of Massachusetts, Worcester
Last Modified on15 June 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note