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Alpha-2 Agonist

Dexmedetomidine + Midazolam for Pediatric Delirium

Phase 4

Recruiting

Led By R. Ian Richmond, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-48 hours

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial found that preoperative use of intra-nasal Dexmedetomidine and oral Midazolam was effective in preventing emergent delirium in pediatric ambulatory surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Dexmedetomidine include low blood pressure, slow heart rate, dry mouth, and nausea. Midazolam may cause drowsiness, headache, vomiting, and mood changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two days post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two days post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and two days post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of pediatric delirium

Time to offset of pediatric delirium

Time to onset of pediatric delirium

Secondary study objectives

Drug Acceptance

End tidal Sevoflurane value

Home Behavior Analysis

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intra-nasal DexmedetomidineExperimental Treatment1 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 MidazolamActive Control1 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.

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