Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy

NCT07176533 | Not Yet Recruiting

• 1 other identifier: SZMN inTonsillectomy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tonsillitis

Keywords

Pain control; Tonsillectomy; Adenotonsillectomy; Suprazygomatic maxillary nerve block; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Impact of the suprazygomatic maxillary (SZMN) nerve block on opioid consumption in IV morphine equivalents in post-anesthesia care unit (PACU).

  This will be measured by evaluating the morphine consumption of participants during their time in the PACU and comparing the opioid requirements between study groups.

  0-24 hours following surgery

Secondary Outcomes (7)

• Impact of the suprazygomatic maxillary (SZMN) nerve block on intraoperative and postoperative opioid consumption in IV morphine equivalents

  During surgery - 14 days following surgery.

• Impact of the suprazygomatic maxillary (SZMN) nerve block on postoperative pain scores

  At completion of surgery - 14 days postoperative

• Impact of the suprazygomatic maxillary (SZMN) nerve block on postoperative complications

  At completion of surgery - 14 days postoperative

• Impact of the suprazygomatic maxillary (SZMN) nerve block on the requirement for postoperative non-opioid analgesic consumption

  At completion of surgery - 14 days postoperative

• Impact of the suprazygomatic maxillary (SZMN) nerve block on the results of the Parental Satisfaction Questionnaire

  At completion of surgery - 14 days postoperative

Study Arms (2)

Suprazygomatic maxillary nerve block (SZMN) with bupivacaine

EXPERIMENTAL

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.

Procedure: Suprazygomatic maxillary nerve block (SZMN) with bupivacaine

Suprazygomatic maxillary nerve block (SZMN) with placebo

PLACEBO COMPARATOR

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.

Procedure: Suprazygomatic maxillary nerve block (SZMN) with placebo

Interventions

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.

Suprazygomatic maxillary nerve block (SZMN) with placebo

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 bupivacaine

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients undergoing coblation intracapsular tonsillectomy or adenotonsillectomy for sleep apnoea.
• Between 3-9 years old (inclusive).
• Patient(s) and guardian(s) can consent to participate in the study.
• Legal guardian(s) can read and write in English.

You may not qualify if:

• Patient or legal guardian refusal to participate in the study.
• Emergency surgery.
• Allergies to local anesthetics.
• Patients with coagulopathy.
• Congenital facial abnormalities including (but not limited to) hemifacial microsomia, maxillary hypoplasia, Treacher-Collins syndrome, and Goldenhar syndrome.
• Developmental delay or neurological impairment including (but not limited to) Trisomy 21, cerebral palsy, and autism spectrum disorder.
• Previous airway surgery or a known or predicted airway difficulty.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (10)

• Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27.

  PMID: 25241379 BACKGROUND

• Alm F, Lundeberg S, Ericsson E. Postoperative pain, pain management, and recovery at home after pediatric tonsil surgery. Eur Arch Otorhinolaryngol. 2021 Feb;278(2):451-461. doi: 10.1007/s00405-020-06367-z. Epub 2020 Sep 26.

  PMID: 32980893 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.

  PMID: 30798778 BACKGROUND

• Subramanyam R, Varughese A, Kurth CD, Eckman MH. Cost-effectiveness of intravenous acetaminophen for pediatric tonsillectomy. Paediatr Anaesth. 2014 May;24(5):467-75. doi: 10.1111/pan.12359. Epub 2014 Mar 5.

  PMID: 24597962 BACKGROUND

• Brown KA, Laferriere A, Moss IR. Recurrent hypoxemia in young children with obstructive sleep apnea is associated with reduced opioid requirement for analgesia. Anesthesiology. 2004 Apr;100(4):806-10; discussion 5A. doi: 10.1097/00000542-200404000-00009.

  PMID: 15087614 BACKGROUND

• Jensen DR. Pharmacologic management of post-tonsillectomy pain in children. World J Otorhinolaryngol Head Neck Surg. 2021 May 29;7(3):186-193. doi: 10.1016/j.wjorl.2021.03.004. eCollection 2021 Jul.

  PMID: 34430826 BACKGROUND

• Lin C, Abboud S, Zoghbi V, Kasimova K, Thein J, Meister KD, Sidell DR, Balakrishnan K, Tsui BCH. Suprazygomatic Maxillary Nerve Blocks and Opioid Requirements in Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):564-571. doi: 10.1001/jamaoto.2024.1011.

  PMID: 38780948 BACKGROUND

• Echaniz G, De Miguel M, Merritt G, Sierra P, Bora P, Borah N, Ciarallo C, de Nadal M, Ing RJ, Bosenberg A. Bilateral suprazygomatic maxillary nerve blocks vs. infraorbital and palatine nerve blocks in cleft lip and palate repair: A double-blind, randomised study. Eur J Anaesthesiol. 2019 Jan;36(1):40-47. doi: 10.1097/EJA.0000000000000900.

  PMID: 30308523 BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

MeSH Terms

Conditions

Tonsillitis; Agnosia

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abhijit Biswas

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Biswas

CONTACT

5196858500; abhjit.biswas@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor

Model Details: Single-center prospective randomized controlled trial of suprazygomatic maxillary nerve block with placebo for pediatric patient undergoing tonsillectomy or adenotonsillectomy.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share