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

Primary Purpose

Postoperative Pain, Opioid Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SZMN block
SZMN block with Dexmedetomidine
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Suprazygomatic maxillary nerve block, Tonsillectomy and Adenoidectomy, Regional Anesthesia, Dexmedetomidine, Pediatric

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    SZMN Treatment Group

    SZMN+Dexmedetomidine Treatment Group

    No Intervention: Control Group

    Arm Description

    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.

    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).

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

    Outcomes

    Primary Outcome Measures

    Postoperative Surgical Pain
    Patients will rate their pain on a 0-10 scale
    Postoperative Opioid Consumption
    Amount of pain medications consumed by patients will be recorded

    Secondary Outcome Measures

    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
    Complications from block
    Nerve block complications will be monitored and recorded

    Full Information

    First Posted
    January 12, 2022
    Last Updated
    July 11, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05208892
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Opioid Use
    Keywords
    Suprazygomatic maxillary nerve block, Tonsillectomy and Adenoidectomy, Regional Anesthesia, Dexmedetomidine, Pediatric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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).
    Masking
    ParticipantCare Provider
    Masking Description
    All three groups will receive a small circular band-aid on their temples (site of suprazygomatic maxillary nerve block placement).
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SZMN Treatment Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    SZMN+Dexmedetomidine Treatment Group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    No Intervention: Control Group
    Arm Type
    No Intervention
    Arm Description
    Patients in this group will receive the standard of care for T&A procedures within the pediatric population.
    Intervention Type
    Procedure
    Intervention Name(s)
    SZMN block
    Intervention Description
    Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally
    Intervention Type
    Procedure
    Intervention Name(s)
    SZMN block with Dexmedetomidine
    Intervention Description
    Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally
    Primary Outcome Measure Information:
    Title
    Postoperative Surgical Pain
    Description
    Patients will rate their pain on a 0-10 scale
    Time Frame
    Time Frame: 14 days after surgery
    Title
    Postoperative Opioid Consumption
    Description
    Amount of pain medications consumed by patients will be recorded
    Time Frame
    Time Frame: 14 days after surgery
    Secondary Outcome Measure Information:
    Title
    Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness
    Description
    Adverse events following the procedure will be monitored and recorded
    Time Frame
    Time Frame: 14 days after surgery
    Title
    Complications from block
    Description
    Nerve block complications will be monitored and recorded
    Time Frame
    Time Frame: 14 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ban CH Tsui, MD
    Phone
    (650) 200-9107
    Email
    bantsui@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ksenia Kasimova, MD
    Phone
    (650) 788-9458
    Email
    kasimova@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ban CH Tsui, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Stephanie Pan, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18983373
    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.
    Results Reference
    background
    PubMed Identifier
    24525630
    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.
    Results Reference
    background

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

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