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

Stanford University

Status: Enrolling

Conditions: Postoperative Pain; Opioid Use

Treatments: Procedure: SZMN block; Procedure: SZMN block with Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05208892

64309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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90 participants in 3 patient groups

SZMN Treatment Group

Experimental group

Description:

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.

Treatment:

Procedure: SZMN block

SZMN+Dexmedetomidine Treatment Group

Experimental group

Description:

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).

Treatment:

Procedure: SZMN block with Dexmedetomidine

No Intervention: Control Group

No Intervention group

Description:

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