Efficacy of ultrasound-guided maxillary nerve block in postoperative analgesia for pediatric palatine tonsillectomy and adenoidectomy: a prospective randomized, double-blind, placebo-controlled trial

JRCT ID: jRCT1011210004

Registered date:27/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Tonsillectomy and adenoidectomy
• Date of first enrollment: 08/04/2021
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Consent will be obtained from patients and their guardians on the day before surgery, and the groups will be randomly assigned. On the day of surgery, midazolam syrup 0.5 mg/kg will be administered 30 minutes before entering the operating room. After entering the operating room, general anesthesia will be induced. Ultrasound-guided maxillary nerve block with a local anesthetic (0.2% ropivacaine) at a dose of 0.15 mL/kg or local injection of saline at a dose of 0.15 mL/kg is performed according to the allocation on the previous day. As in conventional pain management methods, saline injection by the surgeon is performed immediately before the procedure. The amount of narcotic analgesics used intraoperatively and pain assessment immediately after awakening from anesthesia, at 2 hours, and at 4 hours will be performed. Postoperatively, the patient should be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring tracheal intubation or ventilatory management. From the day after surgery onward, in addition to the usual postoperative rounds, pain assessment should be performed at 24 hours. The patient will be monitored for hypoxic events (SpO2<92%) and airway-related adverse events requiring intubation or ventilatory management until 24 hours after surgery.

Outcome(s)

• Primary Outcome: FLACC scores immediately after surgery, 2 hours, 4 hours, and 24 hours after surgery

Secondary Outcome

Intraoperative opioid use (fentanyl, remifentanil)
CHEOPS score immediately after surgery, 2 hours, 4 hours, and 24 hours after surgery
Face scale immediately after surgery, 2 hours, 4 hours, and 24 hours after surgery
Mother's satisfaction (NRS: 0-10) at 24 hours after surgery
Time to first use of rescue analgesia after surgery
Number of rescue analgesics used in the first 24 hours after surgery
Time to postoperative drinking
Time to postoperative drinking
Time to postoperative feeding
Incidence of adverse events (nausea and vomiting, hypoxic events (SpO2<92%), airway-related adverse events requiring tracheal intubation and ventilatory management)

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: <= 7age old
• Gender: Both

Include criteria

Pediatric patients undergoing palatine tonsillectomy and adenoidectomy under general anesthesia
Age range: 3-7 years
Selection criteria
Pediatric patients who will undergo palatine tonsillectomy only
Pediatric patients undergoing palatine tonsillectomy and adenoidectomy

Exclude criteria

Patients who are allergic to ropivacaine
Patients who have an anatomical abnormality in the area where maxillary nerve block is performed.
Patients who are judged by the anesthesiologist in charge, the principal investigator, or the sub-investigator to be inappropriate for participation in this study.

Related Information

• Primary Sponsor: Chaki Tomohiro
• Secondary Sponsor: Yamakage Michiaki