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

Tunis University

Status and phase: Completed; Phase 4

Conditions: Perioperative Respiratory Complications; Upper Respiratory Tract Infections

Treatments: Drug: Saline (NaCl 0,9 %) (placebo); Drug: Lidocaine (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT06584461

092023

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 12 months to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

Group L: IV Lidocaine Group

Experimental group

Description:

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..

Treatment:

Drug: Lidocaine (drug)

Group P: Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

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