Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery (LETSVN)

September 22, 2015 updated by: Pontificia Universidad Catolica de Chile

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group L
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
Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
Placebo Comparator: Group P
Normal saline solution administered under the same regimen
Drug: Normal saline
Sodium Chloride 0.9% infusion
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Fernando R Altermatt, MD, Pontificia Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG 08-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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