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

ConditionPostoperative Respiratory Complication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-16
SponsorSakarya University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nebulize Lidocaine

    Drug

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

  • Nebulize %3 Sodium Chloride

    Drug

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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Grup LExperimental treatment 1 intervention
Group B: Grup HExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
4 hours postoperatively

Secondary outcomes

1

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.

Time frame
4 hours postoperatively
2

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.

Time frame
4 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: