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

NCT06584461 | Completed Phase 4

• 1 other identifier: 092023
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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. 1.Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
2. 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.

Conditions

Upper Respiratory Tract Infections; Perioperative Respiratory Complications

Keywords

upper respiratory tract infections; IV lidocaine; General anesthesia; children; laryngospasm; bronchospasm; cough; perioperative respiratory complications

Outcome Measures

Primary Outcomes (1)

• Incidence of Perioperative Respiratory Complications

  Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.

  Within the first 2 hours post-operation.

Secondary Outcomes (1)

• Incidence of Side Effects Related to IV Lidocaine

  Within the first 24 hours post-operation.

Study Arms (2)

Group L: IV Lidocaine Group

EXPERIMENTAL

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..

Drug: Lidocaine (drug)

Group P: Placebo Group

PLACEBO COMPARATOR

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.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Lidocaine (drug) DRUG

IV lidocaine, administered once during the induction of anesthesia.

Group L: IV Lidocaine Group

Saline (NaCl 0,9 %) (placebo) DRUG

IV placebo (normal saline), administered once during the induction of anesthesia.

Group P: Placebo Group

Eligibility Criteria

• Age: 12 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Bechir Hamza Children's Hospital

Tunis, 1029, Tunisia

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Laryngismus; Bronchial Spasm; Cough

Interventions

Lidocaine; Pharmaceutical Preparations; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Vocal Cord Dysfunction; Laryngeal Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Bronchial Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Anesthesiology and Intensive Care, head chief of the department of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: January 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)