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Completed

NCT Number: NCT05208892

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

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.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Childrens Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SZMN Block

Procedure

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally

SZMN block with Dexmedetomidine

Procedure

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

Primary outcomes

  1. Postoperative Surgical Pain

    Time frame: Time Frame: 14 days after surgery

    Patients will rate their pain on a 0-10 scale

  2. Postoperative Opioid Consumption

    Time frame: Time Frame: 14 days after surgery

    Amount of pain medications consumed by patients will be recorded

Secondary outcomes

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

    Time frame: Time Frame: 14 days after surgery

    Adverse events following the procedure will be monitored and recorded

  2. Complications from block

    Time frame: Time Frame: 14 days after surgery

    Nerve block complications will be monitored and recorded

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Dexmedetomidine Use in Suprazygomatic Maxillary Nerve Blocks for Pediatric Adenotonsillectomy Pain Control

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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