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NCT Number: NCT06584461

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

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.

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Key information

Conditions

Upper Respiratory Tract Infections Bronchial Diseases Bronchial Spasm Cough Infections Laryngeal Diseases Laryngismus Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Perioperative Respiratory Complications Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Vocal Cord Dysfunction

Age range

12 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bechir Hamza Children's Hospital

Tunis, 1029, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine (drug)

Drug

IV lidocaine, administered once during the induction of anesthesia.

Saline (NaCl 0,9 %) (placebo)

Drug

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

Primary outcomes

  1. Incidence of Perioperative Respiratory Complications

    Time frame: 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 outcomes

  1. Incidence of Side Effects Related to IV Lidocaine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 4, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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