Postoperative Nausea and Vomiting | Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery
Postoperative Nausea and Vomiting research study
What is the primary objective of this study?
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Postoperative Nausea and Vomiting
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LidocaineBolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
Drug:Normal salineSodium Chloride 0.9% infusion
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group LGroup 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
Group PNormal saline solution administered under the same regimen
Start Date: March 2012
Completed Date: June 2013
Phase: Phase 4
Primary Outcome: 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
Secondary Outcome: The prevention of the composite "nausea / or vomiting"
Study sponsors, principal investigator, and references
Principal Investigator: Fernando R Altermatt, MD
Lead Sponsor: Pontificia Universidad Catolica de Chile