Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Certain studies in the literature have investigated preoperative premedication strategies to reduce the incidence of postoperative respiratory adverse events. However, our literature review revealed no studies evaluating the postoperative beneficial effects of the preoperative nebulized use of the agents planned in our study. Based on this gap, we designed this study with the aim of contributing new data to the current literature.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grup L | Experimental | Patients will receive 0.2 ml/kg of nebulized lidocaine under monitoring, with the treatment completed 15 minutes prior to the surgical procedure. |
|
| Grup H | Experimental | 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulize Lidocaine | Drug | Preoperative administration of lidocaine via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation | 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. | 4 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Preoperative Nebulized Lidocaine and 3% NaCl on cough | To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-cough in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Postoperative cough will be assessed using a 4-point cough severity scale (0 = no cough, 1 = mild intermittent cough, 2 = frequent cough, 3 = severe or persistent cough). A score ≥2 will be considered clinically significant. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burçin Alaçam, MD | Contact | +905465903851 | burcin.ersoy90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Burçin Alaçam, MD | Sakarya University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943745 | Background | Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473. | |
| 40396523 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
This study uses a parallel assignment design in which pediatric patients undergoing adenoidectomy and/or adenotonsillectomy are randomly assigned to one of the intervention groups. Each participant will receive only one type of preoperative nebulized treatment (lidocaine, 3% hypertonic saline, or control), and outcomes will be compared between the groups throughout the study period.
Not provided
Not provided
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.
| Nebulize %3 Sodium Chloride | Drug | Preoperative administration of 3% hypertonic saline via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications. |
|
|
| 4 hours postoperatively |
| Effect of Preoperative Nebulized Lidocaine and 3% NaCl on bronkospasm | To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-bronkospasm in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Bronchospasm will be assessed using a 4-point bronchospasm severity scale: 0 = no bronchospasm; 1 = mild wheezing without increased respiratory effort; 2 = moderate bronchospasm with increased respiratory effort and audible wheezing; 3 = severe bronchospasm with marked respiratory distress, significant desaturation, or silent chest. A score ≥2 will be considered clinically significant. | 4 hours postoperatively |
| Jarraya A, Kammoun M, Cherif O, Khcherem J, Abdelhedi A, Mhiri R. Preoperative nebulised lidocaine for children with mild symptoms of upper respiratory tract infections: A randomised controlled trial. J Perioper Pract. 2025 Jun;35(6):278-284. doi: 10.1177/17504589241276651. Epub 2024 Sep 18. |
| Aniline Compounds |
| D000588 | Amines |