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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01986309

Acronym

LETSVN

Enrollment

Registered

2013-11-18

Start date

2012-03-31

Completion date

2013-06-30

Last updated

2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative Nausea and Vomiting

Keywords

Postoperative, Nausea, Vomiting, Pain, Surgery

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.

Interventions

DRUGNormal saline

Sodium Chloride 0.9% infusion

DRUGLidocaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

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.

Design outcomes

Primary

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	24 hours

Secondary

Measure	Time frame
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
The prevention of the composite nausea / or vomiting	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
Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate	24 hours

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026