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

NCT05208892 | Completed

• 1 other identifier: 64309
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Opioid Use

Keywords

Suprazygomatic maxillary nerve block; Tonsillectomy and Adenoidectomy; Regional Anesthesia; Dexmedetomidine; Pediatric

Outcome Measures

Primary Outcomes (2)

• Postoperative Surgical Pain

  Patients will rate their pain on a 0-10 scale

  Time Frame: 14 days after surgery

• Postoperative Opioid Consumption

  Amount of pain medications consumed by patients will be recorded

  Time Frame: 14 days after surgery

Secondary Outcomes (2)

• Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness

  Time Frame: 14 days after surgery

• Complications from block

  Time Frame: 14 days after surgery

Study Arms (3)

SZMN Treatment Group

EXPERIMENTAL

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.

Procedure: SZMN block

SZMN+Dexmedetomidine Treatment Group

EXPERIMENTAL

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).

Procedure: SZMN block with Dexmedetomidine

No Intervention: Control Group

NO INTERVENTION

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

Interventions

SZMN block PROCEDURE

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally

SZMN Treatment Group

SZMN block with Dexmedetomidine PROCEDURE

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

SZMN+Dexmedetomidine Treatment Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 18983373 BACKGROUND

• 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.

  PMID: 24525630 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ban CH Tsui, MD

  Stanford University

  STUDY DIRECTOR

• Stephanie Pan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All three groups will receive a small circular band-aid on their temples (site of suprazygomatic maxillary nerve block placement).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients in the two intervention groups will receive bilateral suprazygomatic maxillary nerve block such that 5 mL of local anesthetic is deposited on each side. Patients in the SZMN+Dexmedetomidine group will receive Dexmedetomidine in addition to the local anesthetic with placement of the suprazygomatic maxillary nerve block (0.25 mcg/kg on each side for a total dose of 5 mcg/kg, max 20 mcg total).

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: January 29, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)