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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent delirium (confusion and agitation) in young children after surgery. Researchers are testing two treatments: intra-nasal Dexmedetomidine (also known as Precedex) and oral Midazolam, administered before surgery. The goal is to determine which treatment more effectively reduces the chance of delirium during recovery. Children between 3 months and 9 years old, scheduled for ear tube surgery (myringotomy) and generally healthy, are suitable candidates for this trial. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, helping to understand how they benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Dexmedetomidine and Midazolam?

Research has shown that intra-nasal dexmedetomidine can lower the risk of confusion after surgery in children. However, about 37% of children might experience changes in heart function, and around 9% needed dose adjustments due to these changes.

For oral midazolam, studies suggest it might increase the risk of confusion compared to other calming medications, especially at higher doses.

Both treatments have been used in various situations, and research indicates they are generally safe but come with some risks. Dexmedetomidine and midazolam are approved for other uses, meaning they have undergone safety testing, but understanding the specific risks is important. Always discuss with your doctor what this means for your child. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for pediatric delirium because they offer unique approaches compared to traditional medications like haloperidol or risperidone. Intra-nasal Dexmedetomidine is noteworthy for its non-invasive administration method, making it potentially more comfortable and less stressful for young patients. Additionally, it uses a different mechanism by acting as a selective alpha-2 adrenergic agonist, which might offer calming effects without the sedative side effects commonly seen in typical antipsychotics. Oral Midazolam, a known sedative, is being explored as an active comparator to assess its effectiveness and safety in this context, possibly providing quick onset relief. These innovations could lead to more effective and child-friendly interventions for managing delirium in pediatric patients.

What evidence suggests that this trial's treatments could be effective for pediatric delirium?

In this trial, participants will receive either Dexmedetomidine or Midazolam to manage pediatric delirium. Research has shown that using Dexmedetomidine as a nasal spray can help prevent confusion in children after they wake up from anesthesia. One study found that a dose of 1 microgram per kilogram of body weight significantly lowered scores on a test measuring the severity of this confusion. Dexmedetomidine has proven more effective than other calming medications for this purpose.

Oral Midazolam is another treatment option in this trial, used to prevent confusion and effectively calm children before surgery. It helps reduce anxiety and the chance of confusion after surgery. Studies have shown that Midazolam works as well as other methods in reducing anxiety, without causing side effects. Both treatments show promise for managing confusion in children after anesthesia. ^{1 2 5 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11384065/

The effect of dexmedetomidine on emergence delirium of ... DEX demonstrates superior efficacy in preventing ED in pediatric postanesthesia events compared to other sedatives and analgesics.

2. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-024-04832-w

Effects of different doses of intranasal dexmedetomidine on ... However, 1 µg/kg DEX performed the best in reducing Pediatric Anaesthesia Emergence Delirium (PAED) Scale score (SUCRA = 0.88). Conclusion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12460513/

Efficacy and safety of analgosedation with dexmedetomidine ... Dexmedetomidine may reduce delirium risk (RR 0.83 [0.64, 1.07]; low certainty), but impact on withdrawal is uncertain (RR 0.93 [0.55, 1.59]; ...

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1543344/full

Comparative evaluation of intravenous versus intranasal ... The primary outcome was the highest score on the pediatric anesthesia emergence delirium (PAED) score during the first 30 min after awakening.

5. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70020

A systematic review of dexmedetomidine pharmacology in ... Delirium with dexmedetomidine appears inconsistently in pediatrics, and may or may not be correlated with dexmedetomidine. The studies noted ...

6. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-025-06110-9

Intraoperative dexmedetomidine for prevention of ... In conclusion, intraoperative dexmedetomidine was associated with a significantly lower incidence of postoperative delirium in pediatric ...

7. journals.lww.com journals.lww.com/pccmjournal/fulltext/2020/11000/dexmedetomidine_for_prolonged_sedation_in_the.27.aspx

Dexmedetomidine for Prolonged Sedation in the PICU Among the safety profile, 37% cases developed hemodynamic changes, and 9% required intervention in the form of dose reduction in 79% cases. On multivariate ...