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

18 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Dexmedetomidine for pediatric anesthesia?

Research shows that Dexmedetomidine can reduce respiratory issues and improve airway function in children during anesthesia. It is also effective in providing sedation without causing significant breathing problems, making it a good choice for pediatric anesthesia. ^{1 2 3 4 5}

Is oral dexmedetomidine safe for use in children?

Dexmedetomidine has been used safely in children for sedation during procedures, with common side effects including respiratory issues and low blood pressure. It can reduce breathing problems during anesthesia, but caution is advised as it may cause serious heart issues in rare cases. ^{1 2 3 4 6}

How is the drug Dexmedetomidine unique for pediatric anesthesia?

Dexmedetomidine is unique for pediatric anesthesia because it allows children to maintain spontaneous breathing without the need for a breathing tube, providing sedation while avoiding respiratory depression. It is administered orally, which is less invasive compared to other sedatives that require intravenous administration. ^{1 2 7 8 9}

What is the purpose of this trial?

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

Research Team

Soroush Merchant, MD, MS

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

3. Greece 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. [2023]

4. France pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: perioperative applications in children. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. [2013]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: a guide to its use for sedation in the US. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. [2015]