Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control

NCT ID: NCT05208892

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

Patients between 6 months and 18 years undergoing T&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into one of the three groups:

• the suprazygomatic maxillary nerve (SZMN) block treatment cohort
• the SZMN block with Dexmedetomidine treatment cohort
• the control cohort (standard of care).

After anesthesia induction, patients randomized into the SZMN-treatment group or SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room.

Participants enrolled into the control group will receive the standard of care with no changes to their anesthetic or surgical care. This group will not receive the SZMN block.

Postoperative pain scores and opioid consumption for all three groups will be collected in the PACU and for each postoperative day for a total of 14 postoperative days. We will also collect the following data: time to discharge readiness, postoperative nausea/vomiting, emergence delirium, oxygen desaturation and respiratory events, ability to tolerate oral intake, bleeding, hospital readmission, and adverse events related to the nerve block.

Conditions

Postoperative Pain; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SZMN Treatment Group

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 Type: EXPERIMENTAL

SZMN block

Intervention Type: PROCEDURE

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally

SZMN+Dexmedetomidine Treatment Group

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 Type: EXPERIMENTAL

SZMN block with Dexmedetomidine

Intervention Type: PROCEDURE

Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally

No Intervention: Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SZMN block

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally

Intervention Type: PROCEDURE

SZMN block with Dexmedetomidine

Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ages 6 months - 18 years
• Give consent/parental consent to participate in study
• Patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria

• Participants who do not consent or have parental consent
• Patients who require urgent/emergent intervention
• Patients who undergo additional combined surgical procedures with separate incisions (in addition to the adenotonsillectomy)
• Patients with known difficult airway, clinical hemodynamic instability, coagulopathy, chronic pain history, chronic pain medication use, and unrepaired congenital heart disease
• Patients under age 6 months

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Jiaying Pan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ban CH Tsui, MD

Role: STUDY_DIRECTOR

Stanford University

Stephanie Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Childrens Hospital

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ban CH Tsui, MD

Role: CONTACT

bantsui@stanford.edu

(650) 200-9107

Ksenia Kasimova, MD

Role: CONTACT

kasimova@stanford.edu

(650) 788-9458

Facility Contacts

Stephanie Pan, MD

Role: primary

References

Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x.

Reference Type: BACKGROUND

PMID: 18983373 (View on PubMed)

Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.

Reference Type: BACKGROUND

PMID: 24525630 (View on PubMed)

Other Identifiers

64309

Identifier Type: -

Identifier Source: org_study_id