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Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy

StatusRecruiting
PhaseNot applicable
Started2026-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
notable
Recruitment opened
Primary completion moved earlier: 2027-12-31 → 2027-06-30
2025-12-05
minor
Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsSuprazygomatic maxillary nerve block (SZMN) with placebo (Procedure), Suprazygomatic maxillary nerve block (SZMN) with ropivacaine…→Suprazygomatic maxillary nerve block (SZMN) with bupivacaine (Procedure), Suprazygomatic maxillary nerve block (SZMN) with placebo…
Eligibility criteria-1 characters
[...] nsillectomy or adenotonsillectomy for sleep apnoea. Between 13-109 years old (inclusive). Patient(s) and guardian(s) can conse [...]
Secondary endpointsdetails revised at 1 of 7 entries
Study description+344 characters
[...] Group 1: Participants will receive 15 mg/kg of Tylenol and 46 mg/kg of celecoxib (a nonsteroidal anti-inflammatory (NSAID [...] ethasone). The SZMN block will be performed using 0.2 ml/kg bilaterally of 0.25% ropivacainebupivacaine (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 the [...] Group 2: Participants will receive 15 mg/kg of Tylenol and 46 mg/kg of celecoxib (a nonsteroidal anti-inflammatory (NSAID [...] g 0.2 ml/kg of saline (placebo) up to a maximum dose of 5 mL per side. The surgery (tonsillectom [...] [...]
2025-09-09
minor
Original filing
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.
Trial Details
NCT Number NCT07176533
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Tonsillitis
Enrollment 60 participants
Start Date 2026-01-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-22