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

November 25, 2025 updated by: Burçin Alaçam, MD, Sakarya University

The Effect of Preoperative Nebulized Lidocaine and Nebulized 3% NaCl Premedication on Postoperative Respiratory Complications in Pediatric Patients Undergoing Adenoidectomy and/or Adenotonsillectomy Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Nebulize Lidocaine
Preoperative administration of lidocaine via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.
Other Names:
  • Lidocaine
Experimental: 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..
Drug: Nebulize %3 Sodium Chloride
Preoperative administration of 3% hypertonic saline via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.
Other Names:
  • %3 NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation
Time Frame: 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.
4 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on cough
Time Frame: 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-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.
4 hours postoperatively
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on bronkospasm
Time Frame: 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-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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Principal Investigator: Burçin Alaçam, MD, Sakarya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAU-ANE-BA-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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