Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia

Phase 4

Completed

• Conditions: Upper Respiratory Tract Infections; Perioperative Respiratory Complications
• Interventions: Drug: Lidocaine (drug); Drug: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06584461
• Lead Sponsor: Tunis University

Brief Summary

The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:

1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?

2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-05
• Status Verified: 2024-08
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Children aged 1 to 14 years.
• American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
• Scheduled or urgent surgery or radiological exploration under general anesthesia.
• Upper respiratory tract infection (URTI) symptoms present for less than 15 days.

Exclusion Criteria

• Refusal of participation by parents.
• Children on long-term corticosteroid or bronchodilator therapy.
• Contraindications to the use of lidocaine or other drugs used in the protocol.
• Patients who did not adhere to the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L: IV Lidocaine Group	Lidocaine (drug)	Participants in this group will receive a volume of weight\*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia..
Group P: Placebo Group	Saline (NaCl 0,9 %) (placebo)	Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight\*0.15 ml) to the lidocaine group, administered at the induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of Perioperative Respiratory Complications	Within the first 2 hours post-operation.	Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.

Secondary Outcome Measures

Name	Time	Method
Incidence of Side Effects Related to IV Lidocaine	Within the first 24 hours post-operation.	Measure the occurrence of side effects such as nausea, vomiting, cardiac or neurological toxicity, and signs of anaphylaxis following the administration of IV lidocaine.

Trial Locations

Locations (1)

Bechir Hamza Children's Hospital; 🇹🇳 Tunis, Tunisia