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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06584461

Enrollment

102

Registered

2024-09-04

Start date

2023-01-02

Completion date

2024-02-05

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Respiratory Complications, Upper Respiratory Tract Infections

Keywords

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

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.

Interventions

DRUGLidocaine (drug)

IV lidocaine, administered once during the induction of anesthesia.

DRUGSaline (NaCl 0,9 %) (placebo)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

12 Months to 14 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026