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

Postoperative Pain Clinical Trial

— SZMN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797559
• Other study ID #: 60450
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: April 19, 2023

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• SZMN Block
Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally near the temples of the patient

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171. — View Citation

Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Surgical Pain	Patients will rate their pain on a 0-10 scale	7 days after surgery
Secondary	Opioid Consumption	Pain medications consumed by patients will be collected	1-3 hours after surgery (during the patient's stay in post-anesthesia care unit)