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Completed

NCT Number: NCT04797559

SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A

The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T&A.

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Key information

Conditions

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

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucille Packard Children's 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 either the suprazygomatic maxillary nerve (SZMN) block treatment cohort or the control cohort i.e standard of care.

After anesthesia induction, patients randomized into the SZMN- treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones.

Participants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages 0-18
  • 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 are clinically unstable or require urgent/emergent intervention
  • Patients under age 6 months

Treatment and study plan

SZMN Block

Procedure

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally near the temples of the patient

Primary outcomes

  1. Post Surgical Pain

    Time frame: 7 days after surgery

    Patients will rate their pain on a 0-10 scale

Secondary outcomes

  1. Opioid Consumption

    Time frame: 1-3 hours after surgery (during the patient's stay in post-anesthesia care unit)

    Pain medications consumed by patients will be collected

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ]

Acronym: SZMN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2021
Registry last updated
Aug 14, 2023

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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