search
Back to results

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

Primary Purpose

Postoperative Nausea and Vomiting, Pain

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative, Nausea, Vomiting, Pain, Surgery

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group L

Group P

Arm Description

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

Normal saline solution administered under the same regimen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2013
Last Updated
September 22, 2015
Sponsor
Pontificia Universidad Catolica de Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT01986309
Brief Title
Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery
Acronym
LETSVN
Official Title
Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Pain
Keywords
Postoperative, Nausea, Vomiting, Pain, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Normal saline solution administered under the same regimen
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline solution
Intervention Description
Sodium Chloride 0.9% infusion
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The prevention of the composite "nausea / or vomiting"
Time Frame
24 hours
Title
Compare frequency of vomiting by baseline risk
Time Frame
24 hours
Title
Time to first vomiting
Time Frame
24 hours
Title
Time at which discharge criteria are met Postanesthesia care unit (PACU)
Time Frame
24 hours
Title
Length of stay in PACU unit
Time Frame
24 hours
Title
PACU opioid consumption
Time Frame
24 hours
Title
Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate
Time Frame
24 hours
Title
Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale
Time Frame
24 hours
Title
Time to first emetic drug administered
Time Frame
24 hours
Title
Type and number of doses of antiemetic drug required during hospitalization
Time Frame
24 hours
Title
Total length of stay
Time Frame
24 hours
Title
Analysis of cost-effectiveness.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando R Altermatt, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330024
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
29570108
Citation
Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs