Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery

Study Overview
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Brief Summary
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There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.

Detailed Description
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The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.

Official Title
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Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids

Conditions
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Postoperative Nausea and Vomiting, Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 2 and 12 years ASA I or II Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia Exclusion Criteria: Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex. Use of antiemetic drugs during the 24 hours before surgery. Gastroesophageal reflux. History of allergy to any of the drugs used in the study. Down Syndrome.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L<br>Group L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure | Drug: Lidocaine<br>* Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h<br>|
| Placebo Comparator: Group P<br>Normal saline solution administered under the same regimen | Drug: Normal saline<br>* Sodium Chloride 0.9% infusion<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevention of the composite nausea / or vomiting |  | 24 hours | 
| Compare frequency of vomiting by baseline risk |  | 24 hours | 
| Time to first vomiting |  | 24 hours | 
| Time at which discharge criteria are met Postanesthesia care unit (PACU) |  | 24 hours | 
| Length of stay in PACU unit |  | 24 hours | 
| PACU opioid consumption |  | 24 hours | 
| Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate |  | 24 hours | 
| Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale |  | 24 hours | 
| Time to first emetic drug administered |  | 24 hours | 
| Type and number of doses of antiemetic drug required during hospitalization |  | 24 hours | 
| Total length of stay |  | 24 hours | 
| Analysis of cost-effectiveness. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative, Nausea, Vomiting, Pain, Surgery