- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208892
Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control
Dexmedetomidine Use in Suprazygomatic Maxillary Nerve Blocks for Pediatric Adenotonsillectomy Pain Control
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Lucile Packard Childrens Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SZMN Treatment Group
Patients randomized into the SZMN treatment group will receive bilateral single injection SZMN blocks 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 anesthetic per side.
|
Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally
|
|
Experimental: SZMN+Dexmedetomidine Treatment Group
Patients randomized into the SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks 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 anesthetic along with 0.25 mcg/kg (max 10 mcg) Dexmedetomidine on each side (total of 0.5 mcg/kg, total max 20 mcg).
|
Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally
|
|
No Intervention: No Intervention: Control Group
Patients in this group will receive the standard of care for T&A procedures within the pediatric population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Surgical Pain
Time Frame: Time Frame: 14 days after surgery
|
Patients will rate their pain on a 0-10 scale
|
Time Frame: 14 days after surgery
|
|
Postoperative Opioid Consumption
Time Frame: Time Frame: 14 days after surgery
|
Amount of pain medications consumed by patients will be recorded
|
Time Frame: 14 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness
Time Frame: Time Frame: 14 days after surgery
|
Adverse events following the procedure will be monitored and recorded
|
Time Frame: 14 days after surgery
|
|
Complications from block
Time Frame: Time Frame: 14 days after surgery
|
Nerve block complications will be monitored and recorded
|
Time Frame: 14 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie Pan, MD, Stanford University
- Study Director: Ban CH Tsui, MD, Stanford University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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