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

Pain Clinical Trial

— LETSVN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986309
• Other study ID #: PG 08-12
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2013
• Last updated: September 22, 2015
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Lidocaine
Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
• Normal saline
Sodium Chloride 0.9% infusion

Locations

Country	Name	City	State
Chile	División de Anestesia - Facultad de Medicina Pontificia Universidad Católica	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

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