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Completed

NCT Number: NCT01986309

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

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

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, 8330024, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h

normal saline

Drug

Sodium Chloride 0.9% infusion

Other names: Saline solution

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Acronym: LETSVN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2013
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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