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RECRUITING Not applicable ClinicalTrials.gov

Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's • ClinicalTrials.gov ID: NCT07176533

Registry updated: 2026-09-22
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Description

Tonsillectomies are among the most common surgical procedures performed in pediatric populations, with more than 14,000 procedures performed annually in Ontario, with more than 80% being performed to treat sleep-disordered breathing, including sleep apnea. Despite being a routine procedure, postoperative pain is a prevalent challenge following tonsillectomies, with significant pain lasting 7 to 10 days and peaking within the first 3 days following surgery. Effective pain management is critical not only to enhance patient comfort, but to ensure functional recovery, decrease the risk of post-surgical complications, and reduce the risk of hospital readmissions. The suprazygomatic maxillary nerve block (SZMN block) has become a promising alternative to opioids for the management of post-tonsillectomy pain. The SZMN block numbs the nerves in the facial region that would contribute to feeling pain following tonsillectomy. Although the SZMN block has been successful in adult tonsillectomies and pediatric cleft palate repairs, its success in pediatric tonsillectomies remains under investigation. This randomized controlled trial aims to evaluate the efficacy and safety of the SZMN block in pediatric tonsillectomy and adenotonsillectomy patients, through its role in providing pain management over 14 days following surgery. This study will be conducted at Victoria Hospital, London Health Sciences Centre.

Interventions

  • Suprazygomatic maxillary nerve block (SZMN) with bupivacaine (Procedure)
    Participants will receive 15 mg/kg of Tylenol and 6 mg/kg of celecoxib (a nonsteroidal anti-inflammatory (NSAID drug) up to a maximum dose of 200 mg prior to the start of general anesthesia which will consist of gas or intravenous induction (2 mcg/kg fentanyl, 0.5 mg/kg dexamethasone). The SZMN block will be performed using 0.2 ml/kg bilaterally of 0.25% bupivacaine (MARCAINE) (cumulative dose 0.4 ml/kg) (local anesthetic), up to a maximum dose of 5 mL per side. . The surgery (tonsillectomy or adenotonsillectomy) will then proceed according to standard of care practices.
  • Suprazygomatic maxillary nerve block (SZMN) with placebo (Procedure)
    Participants will receive 15 mg/kg of Tylenol and 6 mg/kg of celecoxib (a nonsteroidal anti-inflammatory (NSAID drug) up to a maximum dose of 200 mg prior to the start of general anesthesia. which will consist of gas or intravenous induction (2 mcg/kg fentanyl, 0.5 mg/kg dexamethasone). The SZMN block will be performed using 0.2 ml/kg of saline (placebo) up to a maximum dose of 5 mL per side. The surgery (tonsillectomy or adenotonsillectomy) will then proceed according to standard of care practices.

Eligibility criteria

Inclusion Criteria: 1. Patients undergoing coblation intracapsular tonsillectomy or adenotonsillectomy for sleep apnoea. 2. Between 3-9 years old (inclusive). 3. Patient(s) and guardian(s) can consent to participate in the study. 4. Legal guardian(s) can read and write in English. Exclusion Criteria: 1. Patient or legal guardian refusal to participate in the study. 2. Emergency surgery. 3. Allergies to local anesthetics. 4. Patients with coagulopathy. 5. Congenital facial abnormalities including (but not limited to) hemifacial microsomia, maxillary hypoplasia, Treacher-Collins syndrome, and Goldenhar syndrome. 6. Developmental delay or neurological impairment including (but not limited to) Trisomy 21, cerebral palsy, and autism spectrum disorder. 7. Previous airway surgery or a known or predicted airway difficulty.

Conditions

Tonsillitis

Locations

  • Victoria Hospital, London Health Sciences Center, Western University — London, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record