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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Pontificia Universidad Catolica de Chile
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01986309
First received: July 8, 2013
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Postoperative Nausea and Vomiting
Pain After Surgery
Drug: Lidocaine
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 analoge 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 requiered 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 ]

Estimated Enrollment: 92
Study Start Date: March 2012
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
Placebo Comparator: Group P
Saline solution administered under the same regimen

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986309

Contacts
Contact: Fernando R Altermatt, Assistant Professor +56 2 2354 3270 fernando.altermatt@gmail.com

Locations
Chile
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica Recruiting
Santiago, Región Metropolitana, Chile, 8330024
Contact: Fernando Altermatt, Assistant Professor    +56 2 23548173    fernando.altermatt@gmail.com   
Principal Investigator: Fernando R Altermatt, Assistant Professor         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
  More Information

No publications provided

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01986309     History of Changes
Other Study ID Numbers: PG 08-12
Study First Received: July 8, 2013
Last Updated: November 11, 2013
Health Authority: Chile: Institutional Review Board

Keywords provided by Pontificia Universidad Catolica de Chile:
Postoperative
Nausea
Vomiting
Pain
Surgery

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Vomiting
Nausea
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014