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

Trial Summary

What is the purpose of this trial?

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

Research Team

R. Ian Richmond, MD

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+