The Effect of Preoperative Nebulized Lidocaine and Nebulized 3% NaCl Premedication on Postoperative Respiratory Complications in Pediatric Patients Undergoing Adenoidectomy and/or Adenotonsillectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation
研究概览
简要总结
This prospective, randomized clinical trial aims to evaluate the effect of preoperative nebulized lidocaine and nebulized 3% hypertonic sodium chloride (NaCl) on the incidence of postoperative respiratory complications in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Lidocaine, a versatile sodium channel blocker, has shown antitussive, bronchodilatory, and anti-inflammatory benefits when nebulized, and has been safely used in children for respiratory procedures. Hypertonic 3% NaCl is known to improve mucociliary clearance, reduce airway edema, and enhance secretion mobilization, particularly in pediatric respiratory conditions. Both agents have demonstrated individual safety and efficacy in respiratory management, yet their preoperative nebulized use for preventing postoperative respiratory adverse events (PRAEs) in pediatric airway surgery has not been previously studied. This trial seeks to determine whether preoperative nebulization with these agents can reduce postoperative respiratory complications, improve recovery, and enhance perioperative safety in this high-risk population.
详细描述
Lidocaine is a drug with multiple clinical uses. Beyond its classical indication as a sodium channel blocker in local, regional, and neuraxial anesthesia, it has been:
- administered intravenously as an antitussive agent in ophthalmic surgery,
- used in both human and veterinary anesthesia to reduce the minimum alveolar concentration (MAC),
- applied as an analgesic for acute pain,
- used as an antiarrhythmic for ventricular arrhythmias,
- administered as a cardioplegic agent in cardiac surgery,
- used as a local anesthetic for venous cannulation,
- nebulized during awake airway interventions,
- nebulized in refractory cough, and
- applied into the endotracheal tube cuff to prevent postoperative sore throat.
Nebulized lidocaine has previously been used in adults with chronic obstructive pulmonary disease, acute asthma, and acute lung infections to suppress cough and provide bronchodilation, and has been found safe and effective. High doses (up to 8 mg/kg) of nebulized lidocaine have been safely administered in infants and children prior to flexible bronchoscopy to reduce perioperative respiratory adverse events (PRAEs).
Hypertonic 3% sodium chloride (NaCl) solution is an agent that has been extensively studied and used clinically in respiratory diseases. Its primary mechanisms of action include osmotic rehydration of the airway surface liquid, thinning mucus, and facilitating mucociliary clearance. This reduces secretion viscosity and supports easier mucus removal. It may also reduce airway edema, relieve obstruction, and promote the dissolution of mucus plugs. Some studies suggest it may exert anti-inflammatory effects by limiting inflammatory mediators. In clinical practice, it has been shown to be safe and effective in children with acute bronchiolitis, reducing hospital stay and improving symptoms. In addition, it is used in cystic fibrosis, chronic bronchitis, COPD, and acute pulmonary infections to enhance mucus clearance and improve respiratory function.
Adenoidectomy and tonsillectomy are among the most common surgical procedures performed in the pediatric population, primarily due to recurrent throat infections and sleep-disordered breathing associated with obstructive sleep apnea. Postoperative complications may include bleeding, respiratory distress, airway obstruction, postoperative pain, and dehydration. Reported respiratory complication rates range from 2% to 4%, rising to 13-15% in high-risk groups. Beyond the inherent respiratory risks of the surgery itself, perioperative respiratory adverse events (PRAEs) are highly prevalent in pediatric patients. These include minor events (oxygen desaturation, airway obstruction, cough, or wheezing) and major events (laryngospasm and bronchospasm). Such complications may prolong hospitalization, increase healthcare costs, and cause varying degrees of physical and psychological stress in both children and their caregivers. PRAEs are documented in up to 50% of children undergoing tonsillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
This study is double-blinded. Both the participants and the care providers administering the nebulized treatment will be unaware of the group assignments. The nebulized solutions (lidocaine, 3% hypertonic saline, or control) will be prepared in identical containers with identical appearance to ensure blinding throughout the perioperative period.
入排标准
- 年龄范围
- 18 Months 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agree to participate in the study
- •Patients undergoing adenoidectomy or adenotonsillectomy
- •Patients with ASA physical status 1-2
- •Children aged 18 months to 16 years
排除标准
- •Patients who do not agree to participate in the study
- •Patients with allergy to lidocaine or 3% NaCl
- •Patients with ASA physical status 3-4
- •Patients whose surgery duration exceeds 1 hour
研究组 & 干预措施
Grup L
Patients will receive 0.2 ml/kg of nebulized lidocaine under monitoring, with the treatment completed 15 minutes prior to the surgical procedure.
干预措施: Nebulize Lidocaine (Drug)
Grup H
Patients will receive 0.2 ml/kg of nebulized %3 hypertonic saline under monitoring, with the treatment completed 15 minutes prior to the surgical procedure..
干预措施: Nebulize %3 Sodium Chloride (Drug)
结局指标
主要结局
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation
时间窗: 4 hours postoperatively
To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-postoperative deoxygenation in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. An oxygen saturation value of ≤94% lasting for more than 2 minutes will be considered oxygen desaturation.
次要结局
- Effect of Preoperative Nebulized Lidocaine and 3% NaCl on cough(4 hours postoperatively)
- Effect of Preoperative Nebulized Lidocaine and 3% NaCl on bronkospasm(4 hours postoperatively)
研究者
Burçin Alaçam, MD
medicine doctor
Sakarya University
