Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine Infiltration for Post-Tonsillectomy Analgesia: A Prospective, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Postoperative Pain Intensity Assessed by the Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
Tonsillectomy (tonsil removal) is a very common surgery for children, but it often causes significant throat and ear pain afterward. Doctors usually inject a numbing medicine, such as bupivacaine, into the area around the tonsils to help control this pain. However, these injections require needles, which can cause swelling, distort tissue, and slightly increase the risk of bleeding or infection, and the pain relief typically only lasts for about 4 to 6 hours.
This study is investigating a needle-free alternative to see if it provides effective pain relief. The researchers are testing a medication called magnesium sulfate, which blocks certain pain receptors and can be applied directly to the surgical site using a soaked gauze pad instead of a needle injection.
The main goal of this clinical trial is to compare how well topical magnesium sulfate relieves pain compared to standard bupivacaine injections in children undergoing tonsillectomy.
The study will include 40 children between the ages of 8 and 15 years old. During the surgery, while under general anesthesia, half of the children will receive the topical magnesium sulfate pad applied to the surgical area for 5 minutes, and the other half will receive the standard bupivacaine injection. After the surgery, researchers will measure the children's pain levels using visual pain scales featuring faces and numbers. They will also track how much extra pain medication the children need, how well their surgical wounds heal, and if they experience any adverse effects.
详细描述
Postoperative pain following tonsillectomy is a primary cause of morbidity in the pediatric population, frequently leading to "tonsillectomy distress syndrome," which is characterized by severe odynophagia, referred otalgia, and psychological distress. The underlying pathophysiology of this pain is complex, involving both mechanical trauma to the pharyngeal constrictor muscles and the chemical irritation of the vagus and glossopharyngeal nerve endings.
While perioperative analgesia is traditionally managed with local anesthetic infiltration, such as bupivacaine, its analgesic efficacy is typically limited to a short duration of 4 to 6 hours. Furthermore, the physical act of needle infiltration can induce tissue edema, distort surgical planes, and potentially elevate the risk of postoperative complications, including infection and hemorrhage.
Recent advancements in pain management have highlighted the role of N-methyl-D-aspartate (NMDA) receptors in peripheral tissues, presenting new avenues for non-invasive analgesia. Magnesium sulfate serves as an NMDA receptor antagonist by blocking its calcium channel in a voltage-dependent manner. This trial investigates whether applying magnesium sulfate topically to the tonsillar fossa can provide effective postoperative analgesia without the inherent risks associated with needle infiltration.
To ensure procedural standardization across the study, all tonsillectomies in this prospective, randomized trial will be performed utilizing a cold dissection technique under general anesthesia. Postoperatively, patients will be systematically evaluated to assess pain intensity, mucosal healing via a 5-point fibrin and epithelialization grading scale, and the overall requirement for rescue analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 8-15 years undergoing elective tonsillectomy.
排除标准
- •Patients younger than 8 years or older than 15 years.
- •Known allergy to magnesium sulfate or bupivacaine.
- •Pre-existing neurological disorders (for example, neuromuscular diseases, epilepsy) that could affect pain perception or magnesium metabolism.
- •Pre-existing cognitive impairment or developmental delay affecting pain assessment.
- •Chronic pain syndromes or regular use of analgesics.
- •Coagulopathy or bleeding disorders.
研究组 & 干预措施
Group A: Topical Magnesium Sulfate
Participants in this group will have a sterile gauze soaked in 5 mL of 20% magnesium sulfate (2 mg/kg) packed into the tonsillar fossa for 5 minutes post-hemostasis.
干预措施: Magnesium Sulfate (Drug)
Group B: Peritonsillar Bupivacaine
Participants in this group will receive an injection of 2 mL of 0.25% bupivacaine directly into the peritonsillar space, specifically at the superior, middle, and inferior poles.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Postoperative Pain Intensity Assessed by the Wong-Baker FACES Pain Rating Scale
时间窗: At 24 hours postoperatively
The Wong-Baker FACES Pain Rating Scale is a visual assessment tool that features a series of six cartoon faces showing different emotional expressions to help pediatric patients communicate their pain levels. The scale ranges from a minimum score of 0, which corresponds to a happy, smiling face meaning "No Hurt," to a maximum score of 10, which corresponds to a sad, crying face meaning "Hurts Worst". Higher scores on this scale indicate greater pain intensity, reflecting a worse patient outcome.
次要结局
未报告次要终点
研究者
Abd El-Rahman Ahmed Aboulwafa
Resident of Otolaryngology
Assiut University