Dexmedetomidine for Pediatric Anesthesia

Overseen By Margaret Owens-Stuberfield

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Must not be taking: Anticonvulsants, Opioids, Benzodiazepines, others

Disqualifiers: Lung disease, Heart disease, Obesity, others

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 1

Duration: Single session

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how Dexmedetomidine, a sedative, affects the amount of Sevoflurane needed during surgery in young children. Researchers aim to determine the correct dosage of Dexmedetomidine for children aged 1 month to 3 years. Different groups receive varying doses of the medication or a placebo (a substance with no active drug). Children undergoing surgery without specific health issues, such as asthma flare-ups, certain heart conditions, or developmental disorders, might be suitable candidates. As a Phase 4 trial, this research helps clarify how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications like anticonvulsants, opioids, benzodiazepines, antibiotics, and antihistamines, as they can affect the study's results.

What is the safety track record for Dexmedetomidine?

Research has shown that dexmedetomidine is generally safe for children and is often used for sedation in pediatric care due to its strong safety record. For instance, a review of studies found that dexmedetomidine is commonly and safely used for various procedures in children. One study suggested it might even be more effective than midazolam, a widely used sedative, for calming children before surgery. Although data on its long-term use is limited, current evidence supports the safety of short-term use. Additionally, its use in some treatments for children further supports its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dexmedetomidine for pediatric anesthesia because it offers a unique approach to managing anesthesia in young patients. Unlike traditional anesthetics that primarily work by depressing the central nervous system, dexmedetomidine acts as a selective alpha-2 adrenergic agonist, providing sedation and pain relief without significant respiratory depression. This is particularly advantageous for infants and young children, as it reduces the risk of common anesthesia-related complications like respiratory issues. Additionally, dexmedetomidine has a calming effect, which can help with smoother recovery post-surgery. These features make it a promising alternative to conventional anesthetic options, paving the way for safer pediatric surgical procedures.

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

Research has shown that dexmedetomidine works well for anesthesia in children. Studies have found that it can reduce the amount of anesthesia needed during surgery, enhancing sedation safety. In this trial, participants will receive varying dosages of dexmedetomidine or a placebo to evaluate its effectiveness and safety. In children, dexmedetomidine outperforms midazolam in calming them before surgery and preventing confusion upon waking. It creates favorable conditions for surgery without causing major heart or blood pressure issues. This treatment is well-regarded for making anesthesia safer and more comfortable for children. ^{4 6 7 8 9}

Who Is on the Research Team?

Rahul Baijal, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for children aged 1 month to 3 years who need surgery. It's not for kids with a history of difficult breathing during anesthesia, metabolic diseases like diabetes, or those on certain meds that affect anesthesia. Also excluded are kids with airway issues, heart problems, obesity, premature birth complications, electrolyte imbalances, GI disease, liver or kidney problems.

Inclusion Criteria

I am between 1 month and 3 years old and need surgery.

Exclusion Criteria

I have an abnormality in my airway.

I have irregular heartbeats.

I have a gastrointestinal condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dexmedetomidine or placebo intravenously prior to surgical procedure to assess its effect on the minimum alveolar concentration of Sevoflurane

Single session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine

Trial Overview The study tests how two doses of Dexmedetomidine (0.5mcg/kg and 1mcg/kg) influence the needed amount of Sevoflurane anesthetic in young children undergoing surgery. The goal is to find out if these doses can lower the concentration required safely.

How Is the Trial Designed?

Group I: Dexmedetomidine 0.5 mcg/kg 1-6 months Active Control 1 Intervention

Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group II: Dexmedetomidine 1 mcg/kg 6-12 months Active Control 1 Intervention

Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group III: Dexmedetomidine 1 mcg/kg 1-3 years Active Control 1 Intervention

Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group IV: Dexmedetomidine 0.5 mcg/kg 6-12 months Active Control 1 Intervention

Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group V: Dexmedetomidine 1 mcg/kg 1-6 months Active Control 1 Intervention

Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group VI: Dexmedetomidine 0.5 mcg/kg 1-3 years Active Control 1 Intervention

Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group VII: Placebo 1-6 months Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group VIII: Placebo 6-12 months Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group IX: Placebo 1-3 years Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

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]

Dexmedetomidine is a promising sedative for children in intensive care, showing efficacy in reducing the need for other sedatives and being particularly beneficial for those with neurologic impairments.

While generally well tolerated, dexmedetomidine can cause hypotension and bradycardia in 10% to 20% of patients, necessitating careful monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric intensive care and procedural sedation. Buck, ML.[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]

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 (DEX) is an effective sedative that provides anxiolysis and sedation without causing respiratory depression, making it suitable for use in pediatric intensive care.

In a case involving a three-year-old girl with a pacemaker, DEX administration led to unsuccessful atrial capture, suggesting that caution is needed when using DEX in patients with existing conduction abnormalities or those who are pacemaker-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. Shepard, SM., Tejman-Yarden, S., Khanna, S., et al.[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]

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 of 13,072 children undergoing pediatric procedural sedation with dexmedetomidine (DEX), the overall adverse event rate was low at 3.6%, with serious adverse events (SAEs) occurring in only 0.34% of cases, indicating a high safety profile for DEX in this setting.

The most common serious adverse event was airway obstruction, which occurred in 0.27% of patients, while the sedation success rate was exceptionally high at 99.7%, demonstrating DEX's efficacy in pediatric procedural sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Sulton, C., McCracken, C., Simon, HK., et al.[2017]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11967424/

Effectiveness of dexmedetomidine as a premedication for ... A meta-analysis indicated that dexmedetomidine was effective for preoperative sedation and for preventing emergence delirium; two of these ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003416

Dexmedetomidine in paediatric anaesthesia: a call for ... The principal message of this study is that children receiving dexmedetomidine in the operating room stay longer in the PACU before discharge to the ward.

4. mdpi.com mdpi.com/2077-0383/9/9/2724

Dexmedetomidine: What's New for Pediatrics? A Narrative ... Two mcg/kg IN DEX had better effect on decreasing anesthesia requirements and 1 mcg/kg via the IV route had better anesthesia-sparing effects as compared to ...

5. bjaed.org bjaed.org/article/S2058-5349(20)30078-0/fulltext

Dexmedetomidine in paediatric anaesthesia Dexmedetomidine has been shown to provide satisfactory intraoperative conditions for adenotonsillectomy without adverse haemodynamic effects ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3583774/

Safety and Effectiveness of Dexmedetomidine in the Pediatric ... Dexmedetomidine is a newer sedative with little safety data in pediatrics, particularly for therapy lasting longer than 48 h.

7. fda.gov fda.gov/media/96854/download

Pediatric Focused Safety Review Precedex™ ( ... Information related to studies in pediatric patients added to the labeling in June 2013 initiated this safety review. Page 4. 4. Background Drug ...

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

A systematic review of dexmedetomidine pharmacology in ... Dexmedetomidine is commonly used off-label for continuous and procedural sedation in pediatrics. It is a popular choice because of its safety ...

9. journals.lww.com journals.lww.com/pccmjournal/fulltext/2021/11000/age_specific_dose_regimens_of_dexmedetomidine_for.14.aspx

Age-Specific Dose Regimens of Dexmedetomidine for ... To demonstrate the efficacy, safety, and pharmacokinetics of dexmedetomidine as a potential sedative for pediatric surgery patients in the ICU.