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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208892
• Other study ID #: 64309
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Ban CH Tsui, MD
• Phone: (650) 200-9107
• Email: bantsui[@]stanford.edu
• 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• SZMN block
Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally
• SZMN block with Dexmedetomidine
Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally

Locations

Country	Name	City	State
United States	Lucile Packard Childrens 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	Postoperative Surgical Pain	Patients will rate their pain on a 0-10 scale	Time Frame: 14 days after surgery
Primary	Postoperative Opioid Consumption	Amount of pain medications consumed by patients will be recorded	Time Frame: 14 days after surgery
Secondary	Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness	Adverse events following the procedure will be monitored and recorded	Time Frame: 14 days after surgery
Secondary	Complications from block	Nerve block complications will be monitored and recorded	Time Frame: 14 days after surgery