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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting; Pain

Treatments: Drug: Normal saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01986309

PG 08-12

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

Group L

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Group P

Placebo Comparator group

Description:

Normal saline solution administered under the same regimen

Treatment:

Drug: Normal saline