Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy

ConditionTonsillitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient or legal guardian refusal to participate in the study.

Emergency surgery.

Allergies to local anesthetics.

Patients with coagulopathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suprazygomatic maxillary nerve block (SZMN) with bupivacaine

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Suprazygomatic maxillary nerve block (SZMN) with bupivacaineExperimental treatment 1 intervention
Group B: Suprazygomatic maxillary nerve block (SZMN) with placeboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
0-24 hours following surgery

Secondary outcomes

1

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

This will be measured by evaluating participants' morphine consumption intraoperatively and postoperatively for 14 days following surgery and comparing the opioid requirements between study groups.

Time frame
During surgery - 14 days following surgery.
2

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

This will be measured by assessing patient pain scores using the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Scale in the PACU and on days 1, 7 and 14 following surgery and comparing the results between study groups. The scale ranges from 0-10 with 0 indicating no pain (better outcome) and 10 indicating maximum pain (worse outcome).

Time frame
At completion of surgery - 14 days postoperative
3

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

This will be measured by recording the occurrence of postoperative complications such as nausea and vomiting, respiratory complications, surgical complications, and nerve block complications and comparing the results between study groups.

Time frame
At completion of surgery - 14 days postoperative
4

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

This will be measured by evaluating the participants' consumption of non-opioid analgesics postoperatively for 14 days following surgery and comparing the results between study groups.

Time frame
At completion of surgery - 14 days postoperative

Other outcomes

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