Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

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

PHASE2/PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2024-07-05

Brief Summary

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The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

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Detailed Description

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The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.

Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.

Placebo

Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Interventions

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Lidocaine

Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.

Intervention Type DRUG

Saline

Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Intervention Type DRUG

Other Intervention Names

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Xylocaine, Lidocaine Hydrochloride Placebo

Eligibility Criteria

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Inclusion Criteria

* Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
* American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)

Exclusion Criteria

* Physical or developmental delays
* Psychiatric illness
* Current use of sedative or anticonvulsant medications
* Pre-existing renal disease (ranging from stage 2 \[mild\] to stage 5 \[end stage\])
* Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
* Pre-existing liver disease
* Pre-existing cerebral or neuromuscular disease
* Patient or family history of Malignant Hyperthermia
* Recent history of upper respiratory infection within last 7 days
* Regular use of analgesic medication
* Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
* Other procedure scheduled in addition to tonsillectomy
* History of allergies to local anesthetics

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No