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

Rhode Island Hospital70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Children, Only Tonsillar Hypertrophy Adenoid Hypertrophy

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Pain Scores

FLACC scale includes 5 categories (Face, Legs, Activity, Cry, Consolability) of pain behaviors scored from 0-2 to provide a total pain score ranging from 0 to 10 with higher numbers indicating greater or worse pain.

Time frame: 15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.

Secondary Outcomes

Opioid consumption

Morphine equivalents

Time frame: Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)

Emergence delirium scores

Pediatric Anesthesia Emergence Delirium (PAED) scale to differentiate emergence delirium from postoperative pain. The scale includes 5 categories (eye contact, purposefulness of actions, awareness of surroundings, restlessness, inconsolable) each scored from 0 to 4 to provide a total score ranging from 0 to 20 with higher numbers being worse indicating that the emergence behaviors correlate better with emergence delirium.

Time frame: 5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery

Parental satisfaction with the anesthetic

Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better

Time frame: Evaluated once on postoperative day 1 (or 24 hours after surgery)