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

Phase 4

Completed

• Conditions: Pain; Postoperative Nausea and Vomiting
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT01986309
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Normal saline	Normal saline solution administered under the same regimen
Group L	Lidocaine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Length of stay in PACU unit	24 hours
Compare frequency of vomiting by baseline risk	24 hours
Time at which discharge criteria are met Postanesthesia care unit (PACU)	24 hours
Time to first emetic drug administered	24 hours
Analysis of cost-effectiveness.	24 hours
The prevention of the composite "nausea / or vomiting"	24 hours
Time to first vomiting	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
Type and number of doses of antiemetic drug required during hospitalization	24 hours
Total length of stay	24 hours

Trial Locations

Locations (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica; 🇨🇱 Santiago, Región Metropolitana, Chile