The Effects of Levobupivacaine Versus Levobupivacaine Plus Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the first call for rescue analgesia
研究概览
简要总结
Tonsillectomy is one of the most common surgical performed procedures in children. Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. Postoperative throat pain is a very important and significant problem because it can lead to decreased oral intake and dehydration with subsequent serious complications of dehydration.
详细描述
The idea behind the use of local anesthetic agents in the peri-operative period is not only related to its ability to block peripheral nociceptor transmission after tissue damage but also in preventing sensitization of the central nervous system. Levobupivacaine is new, long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and neurotoxic. However, few studies showed that local infiltration of levobupivacaine reduces the intensity of postoperative pain. Dexmedetomidine is a highly selective α2-adrenoceptor agonist recently introduced to anesthesia practice producing dose-dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. Dexmedetomidine is being used off-label as an adjunctive agent in pediatric patients for sedation and analgesia; in the critical care unit, during non-invasive ( Magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy). It may also decrease opioid usage and anesthesia requirements as seen from adult data prevent emergence delirium and postanesthesia shivering.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight: 10-40 kg
- •American Society of Anesthesiologists ASA physical status: I-II.
- •Operation: elective tonsillectomy (±adenoidectomy) in the otorhinolaryngology department, Assuit University Hospitals due to recurrent or chronic tonsillitis with or without adenoidectomy (using the surgical retraction and bipolar diathermy if indicated).
排除标准
- •Patients having known hypersensitivity to dexmedetomidine or levobupivacaine.
- •Patients with the following conditions: obstructive sleep apnea syndrome (whether confirmed by a polysomnography test or not), previous peritonsillar abscess formation and those with swallowing disorders.
研究组 & 干预措施
Group A
children will receive levobupivacaine 0.25% by peritonsillar infiltration after intubation 3- 5 min before the start of surgery.
干预措施: Levobupivacaine hydrochloride (Drug)
Group B
children will receive levobupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in 4 ml saline 0.9% and given by peritonsillar infiltration (2 ml per tonsil), after intubation 3- 5 min before the start of surgery.
干预措施: Levobupivacaine Hydrochloride + Dexmedetomidine (Drug)
结局指标
主要结局
the first call for rescue analgesia
时间窗: in 24 hours.
pain assessment using the CHEOPS scale
次要结局
- The analgesics consumption(in 24 hours.)
- parental satisfaction(24 hours)
研究者
Ghada Mohammed AboelFadl
Principal Investigator
Assiut University