Dexmedetomidine + Midazolam for Pediatric Delirium

Overseen By Arlene M Williams, RN

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Cardiac defects, Age 10+, ASA III+, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

R. Ian Richmond, MD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

This trial is for children aged 3 months to 9 years who are scheduled for ear surgery (myringotomy) and are generally healthy (ASA class I-II). It's not for kids over age 9, those with serious heart defects, or non-English speakers without short form consent.

Inclusion Criteria

Children between 3 months and 9 years old.

You are going to have ear surgery to insert ear tubes.

American Society of Anesthesiologists (ASA) classification of I - II.

Exclusion Criteria

You have a heart condition that has not been fixed, including a type called cyanotic congenital heart disease.

Non-English language speaker for whom short form consent is not available

You have a high risk of medical complications according to your health assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive either intra-nasal Dexmedetomidine or oral Midazolam before surgery

10-25 minutes

1 visit (in-person)

Surgery and Immediate Postoperative

Surgery is performed and immediate postoperative monitoring occurs, including documentation of end tidal Sevoflurane value and rescue analgesia in PACU

0-6 hours

Follow-up

Participants are monitored for pediatric delirium and oral analgesic use, with home behavior analysis for 48 hours post-operatively

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Midazolam

Trial Overview The study tests if using intra-nasal Dexmedetomidine or oral Midazolam before surgery can prevent confusion and agitation (delirium) in kids after they wake up from anesthesia in outpatient ear surgeries.

How Is the Trial Designed?

Group I: Intra-nasal Dexmedetomidine Experimental Treatment 1 Intervention

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.

Group II: Oral Midazolam Active Control 1 Intervention

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.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+