Dexmedetomidine Use in Suprazygomatic Maxillary Nerve Blocks for Pediatric Adenotonsillectomy Pain Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Postoperative Surgical Pain
研究概览
简要总结
The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.
详细描述
Patients between 6 months and 18 years undergoing T&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into one of the three groups:
- the suprazygomatic maxillary nerve (SZMN) block treatment cohort
- the SZMN block with Dexmedetomidine treatment cohort
- the control cohort (standard of care).
After anesthesia induction, patients randomized into the SZMN-treatment group or SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room.
Participants enrolled into the control group will receive the standard of care with no changes to their anesthetic or surgical care. This group will not receive the SZMN block.
Postoperative pain scores and opioid consumption for all three groups will be collected in the PACU and for each postoperative day for a total of 14 postoperative days. We will also collect the following data: time to discharge readiness, postoperative nausea/vomiting, emergence delirium, oxygen desaturation and respiratory events, ability to tolerate oral intake, bleeding, hospital readmission, and adverse events related to the nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
All three groups will receive a small circular band-aid on their temples (site of suprazygomatic maxillary nerve block placement).
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6 months - 18 years
- •Give consent/parental consent to participate in study
- •Patients undergoing tonsillectomy and adenoidectomy
排除标准
- •Participants who do not consent or have parental consent
- •Patients who require urgent/emergent intervention
- •Patients who undergo additional combined surgical procedures with separate incisions (in addition to the adenotonsillectomy)
- •Patients with known difficult airway, clinical hemodynamic instability, coagulopathy, chronic pain history, chronic pain medication use, and unrepaired congenital heart disease
- •Patients under age 6 months
研究组 & 干预措施
SZMN Treatment Group
Patients randomized into the SZMN treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic per side.
干预措施: SZMN block (Procedure)
SZMN+Dexmedetomidine Treatment Group
Patients randomized into the SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic along with 0.25 mcg/kg (max 10 mcg) Dexmedetomidine on each side (total of 0.5 mcg/kg, total max 20 mcg).
干预措施: SZMN block with Dexmedetomidine (Procedure)
No Intervention: Control Group
Patients in this group will receive the standard of care for T&A procedures within the pediatric population.
结局指标
主要结局
Postoperative Surgical Pain
时间窗: Time Frame: 14 days after surgery
Patients will rate their pain on a 0-10 scale
Postoperative Opioid Consumption
时间窗: Time Frame: 14 days after surgery
Amount of pain medications consumed by patients will be recorded
次要结局
- Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness(Time Frame: 14 days after surgery)
- Complications from block(Time Frame: 14 days after surgery)
研究者
Stephanie Jiaying Pan
Clinical Assistant Professor
Stanford University