Nerve Block for Pain Management in Pediatric Tonsillitis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Abhijit Biswas
Principal Investigator
London Health Sciences Centre
Are You a Good Fit for This Trial?
This trial is for children aged 1 to 10 years who are having a tonsillectomy or adenotonsillectomy for sleep apnea. Both the child and their legal guardian must be able to give consent, and guardians need to read and write in English.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Suprazygomatic maxillary nerve block (SZMN) with bupivacaine
- Suprazygomatic maxillary nerve block (SZMN) with placebo
Trial Overview
The study compares two groups of children: one receives a suprazygomatic maxillary nerve block (SZMN) with bupivacaine (a numbing medicine), while the other gets an SZMN block with a placebo. The goal is to see if this nerve block helps manage pain after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
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