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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2023-04-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Both groups will receive a small circular band-aid on their temples.

Study Groups

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SZMN Treatment Group

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 through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthestic per side.

Group Type EXPERIMENTAL

SZMN Block

Intervention Type PROCEDURE

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SZMN Block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes