Dexmedetomidine for Postoperative Pain in Pediatric T&A

Overseen By Ksenia Kasimova, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Chronic pain medications

Disqualifiers: Difficult airway, Hemodynamic instability, Coagulopathy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T\&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T\&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with a history of chronic pain medication use.

What data supports the effectiveness of the drug Dexmedetomidine for postoperative pain in pediatric T&A?

Research shows that Dexmedetomidine is effective in reducing pain and anxiety in children during and after surgery. It has been found to extend the duration of pain relief and reduce the need for additional pain medication in pediatric surgeries, making it a reliable option for managing postoperative pain. ^{1 2 3 4 5}

Is dexmedetomidine safe for use in children?

Dexmedetomidine is generally considered safe for use in children, with common side effects including respiratory depression (slowed breathing) and hypotension (low blood pressure). In a study, most adverse effects were mild and consistent with its known safety profile, although there was a case of cardiac arrest in an adult with a pacemaker. ^{1 2 5 6 7}

How is the drug dexmedetomidine (Precedex) unique for managing postoperative pain in pediatric T&A?

Dexmedetomidine (Precedex) is unique because it provides sedation and pain relief without causing breathing problems, unlike some other pain medications. It is also used as an alternative to morphine and can be combined with other pain relievers like acetaminophen for enhanced effect. ^{1 2 3 5 6}

Research Team

Ban CH Tsui, MD

Principal Investigator

Stanford University

Stephanie Pan, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for children aged 6 months to 18 years who are undergoing tonsillectomy and adenoidectomy. They must have consent from themselves or a parent to participate.

Inclusion Criteria

Give consent/parental consent to participate in study

I am having my tonsils and adenoids removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo T&A surgery with or without SZMN block and Dexmedetomidine

1 day

1 visit (in-person, surgical procedure)

Postoperative Monitoring

Postoperative pain scores and opioid consumption are collected for 14 days

14 days

Daily monitoring (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexmedetomidine
• SZMN block

Trial Overview The study tests if the SZMN block, a pain management technique, can help control pain after T&A surgery in kids. It also examines whether adding dexmedetomidine prolongs its pain-relieving effects.

Participant Groups

Group I: SZMN+Dexmedetomidine Treatment Group Experimental Treatment 1 Intervention

Patients randomized into the SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic along with 0.25 mcg/kg (max 10 mcg) Dexmedetomidine on each side (total of 0.5 mcg/kg, total max 20 mcg).

Group II: SZMN Treatment Group Experimental Treatment 1 Intervention

Patients randomized into the SZMN treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic per side.

Group III: No Intervention: Control Group Active Control 1 Intervention

Patients in this group will receive the standard of care for T\&A procedures within the pediatric population.

SZMN block is already approved in European Union, United States, China 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 China as Precedex for:

• Sedation in intensive care settings
• Procedural sedation
• Anesthesia adjunct

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Dexmedetomidine is gaining popularity in pediatric care due to its strong safety and efficacy profile, particularly as an alternative to morphine for pain management in surgeries like craniosynostosis repair.

This study is the first to specifically evaluate the use of dexmedetomidine as a postoperative analgesic and sedative in children after craniosynostosis repair, highlighting a gap in existing research on its application in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. Xu, H., Bui, A., Brown, S., et al.[2021]

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 meta-analysis of 13 randomized trials involving 1033 children, dexmedetomidine was found to provide significantly better sedation at the time of separation from parents compared to midazolam, with 74% of children in the dexmedetomidine group achieving satisfactory sedation versus 50% in the midazolam group.

Dexmedetomidine also significantly reduced postoperative agitation and the need for rescue analgesics, indicating its efficacy in improving overall perioperative experiences for children compared to midazolam.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta-analysis of randomized controlled trials. Pasin, L., Febres, D., Testa, V., et al.[2022]

Dexmedetomidine significantly enhances the duration of analgesia and reduces pain scores in pediatric patients undergoing surgery, based on a meta-analysis of 13 randomized controlled trials involving 722 children.

Despite its benefits, dexmedetomidine does not significantly increase the incidence of side effects compared to placebo, making it a safe and effective adjunct to local anesthetics in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Dexmedetomidine as a Local Anesthetic Adjuvant in Children: A Meta-Analysis of Randomized Controlled Trials. Sun, Y., Wu, Z., Sun, S., 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 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]

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]

References

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

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Dexmedetomidine as a Local Anesthetic Adjuvant in Children: A Meta-Analysis of Randomized Controlled Trials. [2022]

5. 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]

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

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

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

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