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

Phase 4CompletedNCT01986309

Pontificia Universidad Catolica de Chile92 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Nausea and Vomiting Pain

Interventions

LidocaineDRUG

Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h

Normal salineDRUG

Sodium Chloride 0.9% infusion

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

The prevention of the composite "nausea / or vomiting"

Time frame: 24 hours

Compare frequency of vomiting by baseline risk

Time frame: 24 hours

Time to first vomiting

Time frame: 24 hours

Time at which discharge criteria are met Postanesthesia care unit (PACU)

Time frame: 24 hours

Length of stay in PACU unit

Time frame: 24 hours

PACU opioid consumption

Time frame: 24 hours

Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate

Time frame: 24 hours

Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale

Time frame: 24 hours

Time to first emetic drug administered

Time frame: 24 hours

Type and number of doses of antiemetic drug required during hospitalization

Time frame: 24 hours

Data from ClinicalTrials.gov

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