Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Ann & Robert H Lurie Children's Hospital of Chicago89 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

LidocaineDRUG

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

SalineDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Observer Rated Pain Intensity

Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.

Time frame: Within the immediate post-operative period (90 minutes after surgery)

Secondary Outcomes

Patient Rated Pain Intensity

Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals.

Time frame: Within the immediate post-operative period (90 minutes after surgery)

Observer Rated Emergence Delirium

Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.

Time frame: Within the immediate post-operative period (90 minutes after surgery)

Observer Rated PACU Discharge Criteria

Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals.

Time frame: Within the immediate post-operative period (90 minutes after surgery)

Parent Rated Postoperative Pain at Home

Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain.

Time frame: Every day, up to 7 days postoperatively

Medication Journal

Parents will keep a journal of all pain medication given to their children to treat pain.

Time frame: Every day, up to 7 days postoperatively

Data from ClinicalTrials.gov

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