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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986309
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Study Description
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Brief Summary:
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Pain Drug: Lidocaine Drug: Normal saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. The prevention of the composite "nausea / or vomiting" [ Time Frame: 24 hours ]
  2. Compare frequency of vomiting by baseline risk [ Time Frame: 24 hours ]
  3. Time to first vomiting [ Time Frame: 24 hours ]
  4. Time at which discharge criteria are met Postanesthesia care unit (PACU) [ Time Frame: 24 hours ]
  5. Length of stay in PACU unit [ Time Frame: 24 hours ]
  6. PACU opioid consumption [ Time Frame: 24 hours ]
  7. Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate [ Time Frame: 24 hours ]
  8. Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale [ Time Frame: 24 hours ]
  9. Time to first emetic drug administered [ Time Frame: 24 hours ]
  10. Type and number of doses of antiemetic drug required during hospitalization [ Time Frame: 24 hours ]
  11. Total length of stay [ Time Frame: 24 hours ]
  12. Analysis of cost-effectiveness. [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986309


Locations
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Chile
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Región Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Fernando R Altermatt, MD Pontificia Universidad Catolica de Chile
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01986309    
Other Study ID Numbers: PG 08-12
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by Pontificia Universidad Catolica de Chile:
Postoperative
Nausea
Vomiting
Pain
Surgery
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Lidocaine
Anesthetics, Local
Anesthetics
 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