What side effects are associated with this type of intervention?

Dexmedetomidine, an alpha-2 adrenergic agonist used in pediatric anesthesia, is known to reduce anesthetic requirements but can cause side effects such as hypotension, bradycardia, and sedation. Other common treatments in pediatric anesthesia, like ketamine, may cause vivid dreams, hallucinations, and hypertension. Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, often used for pain management, generally have fewer severe side effects but can include gastrointestinal discomfort and liver toxicity, respectively, if used inappropriately.

What prior FDA approvals exist?

Dexmedetomidine, an alpha-2 adrenergic agonist, has been studied for its efficacy in reducing anesthetic requirements in pediatric patients. It is commonly used for its sedative and analgesic properties in various perioperative settings. Other related drugs that have been used in pediatric anesthesia include clonidine, another alpha-2 adrenergic agonist, which is often used off-label for its sedative effects. Additionally, non-opioid analgesics such as acetaminophen and NSAIDs are frequently employed in multimodal pain management strategies to minimize opioid use and enhance postoperative recovery in children.

What other types of research exist?

Promising alternatives to Dexmedetomidine for pediatric anesthesia include newer formulations of existing anesthetics such as Sevoflurane and advancements in multimodal analgesia approaches. Additionally, agents like Remimazolam, a short-acting benzodiazepine, and newer opioid-sparing techniques using drugs like intravenous acetaminophen and ketorolac are being explored for their efficacy and safety in reducing anesthetic requirements in pediatric patients.

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Dexmedetomidine for Pediatric Anesthesia

Phase 4

Recruiting

Led By Rahul Baijal, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

All patients age 1 month- 3 years presenting for surgery.

Be younger than 18 years old

Must not have

Airway malformation

Cardiac arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following skin incision

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing two different amounts of a sedative drug called Dexmedetomidine in young children. The goal is to see if it reduces the amount of another anesthetic, Sevoflurane, needed during surgery. Dexmedetomidine helps calm the patient and reduces stress, which means less Sevoflurane is required. Dexmedetomidine has been studied extensively for its sedative effects in children, showing benefits in reducing the required dose of other anesthetics like Sevoflurane.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth or nausea. In rare cases it might lead to more serious effects like irregular heartbeat but this will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an abnormality in my airway.

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I have irregular heartbeats.

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I have a metabolic condition like diabetes.

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I have liver problems.

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I was born with a heart condition.

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I have a condition affecting my brain such as developmental delay, cerebral palsy, or seizures.

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I or my family have a history of malignant hyperthermia.

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My baby was born before 37 weeks of pregnancy.

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I have kidney problems.

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I have an imbalance in my body's electrolytes.

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My BMI is above the 95th percentile for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following skin incision

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following skin incision

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following skin incision for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Movement

Awards & Highlights

Drug Has Already Been Approved

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

Pivotal Trial

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

Trial Design

9Treatment groups

Active Control

Placebo Group

Group I: Dexmedetomidine 0.5 mcg/kg 1-6 monthsActive Control1 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 monthsActive Control1 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 yearsActive Control1 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 monthsActive Control1 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 monthsActive Control1 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 yearsActive Control1 Intervention

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

Group VII: Placebo 1-6 monthsPlacebo Group1 Intervention

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

Group VIII: Placebo 6-12 monthsPlacebo Group1 Intervention

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

Group IX: Placebo 1-3 yearsPlacebo Group1 Intervention

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dexmedetomidine, an alpha-2 adrenergic agonist, is commonly used in pediatric anesthesia to reduce anesthetic requirements by binding to alpha-2 receptors in the brain and spinal cord, leading to sedation, analgesia, and reduced sympathetic activity. This is significant for pediatric patients as it minimizes the need for other anesthetics and opioids, reducing potential side effects and enhancing recovery. Other treatments like acetaminophen and NSAIDs work by inhibiting cyclooxygenase enzymes to alleviate pain and inflammation. Understanding these mechanisms helps in creating safer and more effective anesthesia plans for children.

Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta-analysis of randomized controlled trials.