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

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Opioid Use
• Interventions: Procedure: SZMN block; Procedure: SZMN block with Dexmedetomidine

• Registration Number: NCT05208892
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2024-01-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SZMN Treatment Group	SZMN block	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.
SZMN+Dexmedetomidine Treatment Group	SZMN block with Dexmedetomidine	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).

Primary Outcome Measures

Name	Time	Method
Postoperative Surgical Pain	Time Frame: 14 days after surgery	Patients will rate their pain on a 0-10 scale
Postoperative Opioid Consumption	Time Frame: 14 days after surgery	Amount of pain medications consumed by patients will be recorded

Secondary Outcome Measures

Name	Time	Method
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	Adverse events following the procedure will be monitored and recorded
Complications from block	Time Frame: 14 days after surgery	Nerve block complications will be monitored and recorded

Trial Locations

Locations (1)

Lucile Packard Childrens Hospital; 🇺🇸 Palo Alto, California, United States