Oral Dexmedetomidine for Pediatric Anesthesia

Overseen By Kelsye Howell, MSN, RN

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Digoxin

Disqualifiers: Unstable cardiac, Moya Moya, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day per MRI session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if oral dexmedetomidine, a sedative, can safely and effectively serve children needing an MRI. Researchers will administer varying doses to identify the optimal one, compared to standard general anesthesia. The trial targets children aged 3-6 who typically require general anesthesia for an MRI. This study could reduce stress for children by eliminating the need for needles and gas masks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are currently using digoxin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexmedetomidine is safe for children. In a large study, more than 13,000 children received dexmedetomidine for sedation, accounting for 5.3% of all sedation cases. The study found no major changes in oxygen levels, indicating safety. Another study found that dexmedetomidine was more effective than midazolam (another sedative) at calming children before separation from their parents, with fewer children feeling agitated upon waking. This evidence supports dexmedetomidine as a safe choice for sedation in children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard of care for pediatric anesthesia, which typically involves general anesthesia, oral dexmedetomidine presents a unique approach. Researchers are excited about dexmedetomidine because it can be administered orally, potentially reducing the need for invasive procedures like IVs. This drug works by targeting the alpha-2 adrenergic receptors, providing sedation with fewer respiratory side effects compared to traditional anesthetics. With varying dosages being explored, from 4 to 12 mcg/kg, there's potential to fine-tune its effectiveness and safety for different needs. Overall, dexmedetomidine offers a promising alternative that could make procedures like MRIs less stressful for children.

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

Research has shown that oral dexmedetomidine effectively calms children, outperforming midazolam, a commonly used sedative for keeping kids calm when separated from their parents. Studies also find that dexmedetomidine achieves the desired level of calmness more successfully than midazolam. This trial will evaluate various dosages of dexmedetomidine, from 4 mcg/kg to 12 mcg/kg, and compare its effectiveness to general anesthesia for children needing sedation during procedures like MRI scans. ^{1 6 7 8 9}

Who Is on the Research Team?

Soroush Merchant, MD, MS

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

This trial is for children aged 4 months to 6 years who need anesthesia for an MRI. They must not be using digoxin, have craniofacial anomalies, recent apnea, or severe medical conditions that make sedation risky. Kids with allergies to dexmedetomidine or certain heart and respiratory diseases can't participate.

Inclusion Criteria

I am between 4 months and 6 years old.

I am scheduled for an MRI with anesthesia for medical reasons.

Exclusion Criteria

I have recently had a stroke.

Known allergy to dexmedetomidine

I refuse to take oral dexmedetomidine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral dexmedetomidine at varying doses 2 hours prior to MRI to assess its utility as a sedative agent

1 day per MRI session

1 visit per MRI session

Follow-up

Participants are monitored for safety and effectiveness after MRI and sedation

Up to 70 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• General Anesthetic

Trial Overview The study is testing if oral dexmedetomidine alone can safely sedate kids during an MRI. It's a preliminary test to see if this method works without needing other general anesthetics.

How Is the Trial Designed?

Group I: Dexmedetomidine 8 mcg/kg Experimental Treatment 1 Intervention

Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI

Group II: Dexmedetomidine 6 mcg/kg Experimental Treatment 1 Intervention

Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI

Group III: Dexmedetomidine 4 mcg/kg Experimental Treatment 1 Intervention

Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI

Group IV: Dexmedetomidine 12 mcg/kg Experimental Treatment 1 Intervention

Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI

Group V: Dexmedetomidine 10 mcg/kg Experimental Treatment 1 Intervention

Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI

Group VI: General anesthesia Active Control 1 Intervention

Control group: Subjects will receive general anesthesia for their MRI

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?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

Intravenous dexmedetomidine is effective for sedation in mechanically ventilated patients and during procedures, reducing the need for additional sedatives like propofol or midazolam.

It is generally well tolerated, does not cause respiratory depression, and while it may lead to hypotension and bradycardia, these side effects typically resolve on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: a guide to its use for sedation in the US. Keating, GM., Hoy, SM., Lyseng-Williamson, KA.[2022]

Dexmedetomidine significantly reduces the incidence of perioperative respiratory adverse events (PRAEs) such as cough, breath holding, and laryngospasm in children, based on a meta-analysis of 10 randomized controlled trials involving 1,056 patients.

In addition to lowering the risk of PRAEs, dexmedetomidine also decreases heart rate and extends post-anesthesia care unit stay by about 11 minutes, indicating its potential to improve airway function and safety during pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. Zhang, J., Yin, J., Li, Y., et al.[2023]

Dexmedetomidine is an alpha-2 adrenergic agonist that provides sedation and pain relief without causing respiratory depression, making it a safe option for patients requiring sedation.

In a case study, dexmedetomidine was effectively used as an adjuvant analgesic for a patient with cancer pain that did not respond to other treatments, highlighting its potential role in managing complex pain scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. Roberts, SB., Wozencraft, CP., Coyne, PJ., et al.[2013]

In a study of 30 patients with liver dysfunction undergoing percutaneous arterial chemoembolization for hepatocellular carcinoma, dexmedetomidine sedation was successfully used in all cases, demonstrating its feasibility for this procedure.

The sedation was generally safe, with only minor adverse events reported in 3 patients, and no serious complications requiring treatment, indicating that dexmedetomidine can be a reliable option for sedation in patients with liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. Komemushi, A., Suzuki, S., Sano, A., et al.[2015]

Dexmedetomidine was safely used to sedate a pediatric patient during 12 radiation therapy sessions, demonstrating its effectiveness as a sedative and anesthetic adjuvant.

The use of dexmedetomidine resulted in smooth induction and quick recovery while causing minimal respiratory depression, highlighting its favorable safety profile in pediatric sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. Shukry, M., Ramadhyani, U.[2013]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889161/

Oral Dexmedetomidine Achieves Superior Effects in Mitigating ... Oral dexmedetomidine may be effective in providing satisfactory sedation and reduce the incidence of emergence agitation, although the results ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4255070/

Premedication with dexmedetomidine in pediatric patients This meta-analysis revealed that dexmedetomidine was superior to midazolam in producing satisfactory sedation in children separated from their parents. The ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02570-1

An evaluation of dexmedetomidine in combination with ... This meta-analysis showed that compared with the control group, dexmedetomidine combined with midazolam group provided higher sedation success rates.

4. link.springer.com link.springer.com/article/10.1007/s40268-025-00522-9

Drugs for Procedural Sedation and Analgesia in Children Other meta-analyses showed that dexmedetomidine had a higher success rate than midazolam, with no significant differences in onset time or ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1089947225000115

Review Intranasal Dexmedetomidine Compared With ... Intranasal dexmedetomidine significantly reduces pediatric ED and improves sedation levels compared with midazolam, but both drugs show similar effects.

6. mdpi.com mdpi.com/2077-0383/13/4/1174

Oral Dexmedetomidine Achieves Superior Effects in ... Notably, our data revealed that the rate of emergence agitation was significantly lower in pediatric patients receiving dexmedetomidine (n = 162) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05619627

NCT05619627 | Oral Dexmedetomidine in Pediatric MRI The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

8. publications.aap.org publications.aap.org/hospitalpediatrics/article/6/9/536/26400/Pediatric-Procedural-Sedation-Using

Pediatric Procedural Sedation Using Dexmedetomidine During the study period, 13 072 children were sedated using DEX, accounting for 5.3% of all sedation cases entered into the PSRC. Of the sedated ...

9. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2017.00529/full

Dexmedetomidine in Pediatric Sedation Study Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation. No major changes in SpO2 were observed, no ...