Clinical trial NCT05208892: Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control
Official title: Dexmedetomidine Use in Suprazygomatic Maxillary Nerve Blocks for Pediatric Adenotonsillectomy Pain Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Keywords: Suprazygomatic maxillary nerve block
Tonsillectomy and Adenoidectomy
Regional Anesthesia
Dexmedetomidine
Pediatric
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients in the two intervention groups will receive bilateral suprazygomatic maxillary nerve block such that 5 mL of local anesthetic is deposited on each side. Patients in the SZMN+Dexmedetomidine group will receive Dexmedetomidine in addition to the local anesthetic with placement of the suprazygomatic maxillary nerve block (0.25 mcg/kg on each side for a total dose of 5 mcg/kg, max 20 mcg total).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Surgical Pain
timeFrame: Time Frame: 14 days after surgery
measure: Postoperative Opioid Consumption
timeFrame: Time Frame: 14 days after surgery
Secondary outcomes:
measure: Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness
timeFrame: Time Frame: 14 days after surgery
measure: Complications from block
timeFrame: Time Frame: 14 days after surgery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital
state: California
Study officials:
affiliation: Stanford University
name: Ban CH Tsui, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Stephanie Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.