Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: Saline

Detailed Description

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
• Enrollment (Actual): 89
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lidocaine; Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.; Other Names: Xylocaine, Lidocaine Hydrochloride
Placebo Comparator: 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.	Drug: Saline; Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within the immediate post-operative period (90 minutes after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Every day, up to 7 days postoperatively

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Hubert Benzon, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

General Publications

• Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
• Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24. doi: 10.1016/s0304-3959(99)00268-7.
• Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. doi: 10.1002/lary.23926. Epub 2013 Apr 17.
• McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimated): November 3, 2015

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 2015-741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO