Clinical trial NCT01986309: Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery
Official title: Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Pain
Keywords: Postoperative
Nausea
Vomiting
Pain
Surgery
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 24 hours
Secondary outcomes:
measure: The prevention of the composite "nausea / or vomiting"
timeFrame: 24 hours
measure: Compare frequency of vomiting by baseline risk
timeFrame: 24 hours
measure: Time to first vomiting
timeFrame: 24 hours
measure: Time at which discharge criteria are met Postanesthesia care unit (PACU)
timeFrame: 24 hours
measure: Length of stay in PACU unit
timeFrame: 24 hours
measure: PACU opioid consumption
timeFrame: 24 hours
measure: Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate
timeFrame: 24 hours
measure: Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale
timeFrame: 24 hours
measure: Time to first emetic drug administered
timeFrame: 24 hours
measure: Type and number of doses of antiemetic drug required during hospitalization
timeFrame: 24 hours
measure: Total length of stay
timeFrame: 24 hours
measure: Analysis of cost-effectiveness.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Fernando R Altermatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807.