Nebulized Lidocaine vs 3% Sodium Chloride in Pediatric Adenoid/Tonsil Surgery

NCT07267897 | Not Yet Recruiting

• 1 other identifier: SAU-ANE-BA-01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Respiratory Complication

Keywords

Postoperative Respiratory Complication; Lidocaine; %3 Sodium Chloride; Pediatric; Adenoidectomy; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Drug: Nebulize Lidocaine

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..

Drug: Nebulize %3 Sodium Chloride

Interventions

Nebulize Lidocaine DRUG

Preoperative administration of lidocaine via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.

Also known as: Lidocaine

Grup L

Nebulize %3 Sodium Chloride DRUG

Preoperative administration of 3% hypertonic saline via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.

Also known as: %3 NaCl

Grup H

Eligibility Criteria

• Age: 18 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Related Publications (2)

• 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.

  PMID: 35943745 BACKGROUND

• 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.

  PMID: 40396523 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Burçin Alaçam, MD

  Sakarya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burçin Alaçam, MD

CONTACT

+905465903851; burcin.ersoy90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medicine doctor

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11