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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine (drug) | Drug | IV lidocaine, administered once during the induction of anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Side Effects Related to IV Lidocaine | Measure the occurrence of side effects such as nausea, vomiting, cardiac or neurological toxicity, and signs of anaphylaxis following the administration of IV lidocaine. | Within the first 24 hours post-operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bechir Hamza Children's Hospital | Tunis | 1029 | Tunisia |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007826 | Laryngismus |
| D001986 | Bronchial Spasm |
| D003371 | Cough |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D064706 | Vocal Cord Dysfunction |
| D007818 | Laryngeal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004364 | Pharmaceutical Preparations |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline (NaCl 0,9 %) (placebo) | Drug | IV placebo (normal saline), administered once during the induction of anesthesia. |
|
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D001982 | Bronchial Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |