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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 Pain Drug: Lidocaine Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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

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   (Child)
Sexes Eligible for Study:   All
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

Keywords provided by Pontificia Universidad Catolica de Chile:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017