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

This study has been completed.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile Identifier:
First received: July 8, 2013
Last updated: September 22, 2015
Last verified: September 2015
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.

Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Lidocaine
Drug: Normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids

Resource links provided by NLM:

Further study details as provided by Pontificia Universidad Catolica de Chile:

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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Enrollment: 92
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Saline solution

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.

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01986309

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Región Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Principal Investigator: Fernando R Altermatt, MD Pontificia Universidad Catolica de Chile
  More Information

Responsible Party: Pontificia Universidad Catolica de Chile Identifier: NCT01986309     History of Changes
Other Study ID Numbers: PG 08-12 
Study First Received: July 8, 2013
Last Updated: September 22, 2015
Health Authority: Chile: Institutional Review Board

Keywords provided by Pontificia Universidad Catolica de Chile:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics, Local
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers processed this record on May 26, 2016