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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain for children undergoing tonsil and adenoid removal surgeries. Researchers aim to determine if a special nerve block, a type of targeted pain relief, can reduce pain and recovery issues. They are also examining whether adding dexmedetomidine (Precedex), a medication known to prolong pain relief, can enhance the nerve block's effectiveness. This study may suit children scheduled for tonsil and adenoid surgery who have no other complicating health conditions. As an unphased trial, it offers a unique opportunity to contribute to innovative pain management strategies for children.

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 prior data suggests that the SZMN block is safe for pediatric T&A procedures?

Research has shown that the suprazygomatic maxillary nerve (SZMN) block safely and effectively manages pain in children after surgery. Studies have found that the SZMN block reduces pain in children undergoing surgeries like tonsil removal. No serious side effects have been reported, making it a well-tolerated option for pain relief.

Dexmedetomidine, tested as an addition to the SZMN block, has significantly reduced post-surgery pain in studies. This medication is already used in other treatments and is known to be safe when administered in the right amounts. Like the SZMN block, dexmedetomidine has not been associated with major side effects in these cases.

Current research indicates that both treatments are safe for children and effectively manage pain, which is crucial for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of using SZMN blocks with and without Dexmedetomidine for reducing postoperative pain in pediatric tonsillectomy and adenoidectomy (T&A) procedures. Unlike the standard approach, which typically involves systemic pain medications like acetaminophen or opioids, the SZMN block provides targeted pain relief at the nerve level through a local anesthetic injected into the pterygomaxillary fossa. What sets the SZMN+Dexmedetomidine treatment apart is the addition of Dexmedetomidine, which enhances pain management by potentially reducing the need for opioids and minimizing their side effects. This localized approach not only aims to improve pain control but also to speed up recovery times for young patients.

What evidence suggests that the SZMN block and dexmedetomidine could be effective for postoperative pain in pediatric T&A?

Research has shown that the suprazygomatic maxillary nerve (SZMN) block can effectively manage pain in children after surgeries like tonsil and adenoid removal. Studies have found that this method significantly lowers pain levels compared to other approaches. In this trial, some participants will receive the SZMN block alone, while others will receive it combined with dexmedetomidine, a medication that aids in pain relief. Early results suggest that adding dexmedetomidine might extend the duration of pain relief, potentially covering the entire postoperative pain period. These findings offer promising evidence for improving pain management in children undergoing these procedures. ^{2 6 7 8 9}

Who Is on the Research Team?

Ban CH Tsui, MD

Principal Investigator

Stanford University

Stephanie Pan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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

I am having my tonsils and adenoids removed.

Give consent/parental consent to participate in study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07176533

Suprazygomatic Maxillary Nerve Block in Pediatric ... This randomized controlled trial aims to evaluate the efficacy and safety of the SZMN block in pediatric tonsillectomy and adenotonsillectomy patients, through ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11117150/

Suprazygomatic Maxillary Nerve Blocks and Opioid ... These results indicate that suprazygomatic nerve blocks provide an effective pain management tool for pediatric intracapsular adenotonsillectomy ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38780948/

Suprazygomatic Maxillary Nerve Blocks and Opioid ... The results of the randomized clinical trial indicate that SZMN blocks are a useful adjunct tool for managing postoperative pain in pediatric intracapsular ...

4. researchgate.net researchgate.net/publication/350235071_Suprazygomatic_maxillary_SZM_nerve_blocks_for_perioperative_pain_control_in_pediatric_tonsillectomy_and_adenoidectomy

Suprazygomatic maxillary (SZM) nerve blocks for ... Four hours after surgery, control of pain was better in the second and third groups in comparison to Groups B and Group C (P <0.05) and was ...

5. joma.amegroups.org joma.amegroups.org/article/view/7304/html

Analgesia for adenotonsillectomy in pediatric patients One study demonstrated propofol-based anesthesia to be associated with significantly lower postoperative pain scores and reduced agitation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12288428/

Dexmedetomidine-Based Anesthesia for Pediatric ... The study demonstrated that local infiltration with dexmedetomidine and ropivacaine significantly reduced postoperative pain in tonsillectomy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1110184911000778

Efficacy and safety of intraoperative dexmedetomidine in ... Intraoperative dexmedetomidine administration resulted in a significant reduction in pain scores postoperatively in the DEX.IV and DEX.PT groups ...

8. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.908212/pdf

Analgesic Effects and Safety of Dexmedetomidine ... These data revealed the safety of nalbuphine combined with dexmedetomidine in PCIA for postoperative pain management in pediatric tonsillectomy ...

9. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03203-x

Effects of Intranasal dexmedetomidine and esketamine for ... Conclusions. Intranasal dexmedetomidine combined with esketamine for premedication was associated with reduced postoperative pain in children.