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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Group P

Normal saline solution administered under the same regimen

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Sodium Chloride 0.9% infusion

Interventions

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Lidocaine

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

Intervention Type DRUG

Normal saline

Sodium Chloride 0.9% infusion

Intervention Type DRUG

Other Intervention Names

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Saline solution

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No