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

Phase 4

Completed

• Conditions: Children, Only; Tonsillar Hypertrophy; Adenoid Hypertrophy
• Interventions: Drug: Lidocaine Iv; Drug: Saline Solution

• Registration Number: NCT03902314
• Lead Sponsor: Rhode Island Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Study Start: 2019-05-07
• Status Verified: 2021-12
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine Iv	Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Saline	Saline Solution	Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.

Primary Outcome Measures

Name	Time	Method
Change in Pain Scores	15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.	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.

Secondary Outcome Measures

Name	Time	Method
Emergence delirium scores	5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery	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.
Parental satisfaction with the anesthetic	Evaluated once on postoperative day 1 (or 24 hours after surgery)	Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better
Opioid consumption	Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)	Morphine equivalents

Trial Locations

Locations (1)

Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States