Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-12-06

Brief Summary

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Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.

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Detailed Description

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The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.

Conditions

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Children, Only Tonsillar Hypertrophy Adenoid Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled patients will be randomly assigned into one of two intervention groups:

Group 1: systemic lidocaine infusion Group 2: normal saline infusion

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Anesthesia care providers will be acquiring the study solution from the institution's pharmacy (lidocaine or saline) to administer perioperatively. The pharmacy will prepare the study solutions per randomization and label the solution as the study solution without reference to lidocaine or saline. Per protocol, the care providers will then administer the study solution as a weight based infusion.

Study Groups

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Lidocaine

Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.

Group Type ACTIVE_COMPARATOR

Lidocaine Iv

Intervention Type DRUG

Intravenous infusion

Saline

Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Intravenous infusion

Interventions

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Lidocaine Iv

Intravenous infusion

Intervention Type DRUG

Saline Solution

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital

Exclusion Criteria

* history of allergies to local anesthetics
* physical or developmental delays
* psychiatric illness
* current use of sedative or anticonvulsive medications
* use of premedication (oral/nasal)
* pre-existing cardiovascular, renal, or hepatic disease
* pre-existing cerebral or neuromuscular disease
* patient with personal or family history of malignant hyperthermia
* recent history of upper respiratory infection within last 7 days
* regular use of analgesic medications

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No