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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902314
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Suh, 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.

Condition or disease Intervention/treatment Phase
Children, Only Tonsillar Hypertrophy Adenoid Hypertrophy Drug: Lidocaine Iv Drug: Saline Solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Enrolled patients will be randomly assigned into one of two intervention groups:

Group 1: systemic lidocaine infusion Group 2: normal saline infusion

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Anesthesia care providers will be acquiring the study solution from the institution's pharmacy (lidocaine or saline) to administer perioperatively. The pharmacy will prepare the study solutions per randomization and label the solution as the study solution without reference to lidocaine or saline. Per protocol, the care providers will then administer the study solution as a weight based infusion.
Primary Purpose: Treatment
Official Title: Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis

Arm Intervention/treatment
Active Comparator: Lidocaine
Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Drug: Lidocaine Iv
Intravenous infusion

Placebo Comparator: Saline
Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Drug: Saline Solution
Intravenous infusion




Primary Outcome Measures :
  1. Change in Pain Scores [ Time Frame: 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 :
  1. Opioid consumption [ Time Frame: Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU) ]
    Morphine equivalents

  2. Emergence delirium scores [ 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 ]
    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.

  3. Parental satisfaction with the anesthetic [ Time Frame: 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



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902314


Contacts
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Contact: Edward I Suh, MD 401-444-5172 esuh@lifespan.org
Contact: Mark Kendall, MD 401-444-4933 mark.kendall@lifespan.org

Locations
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United States, Rhode Island
Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Edward I Suh, MD    401-444-5172    esuh@lifespan.org   
Contact: Mark Kendall, MD    401-444-4933    mark.kendall@lifespan.org   
Principal Investigator: Edward I Suh, MD         
Sub-Investigator: Mark Kendall, MD         
Sub-Investigator: Jan Groblewski, MD         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Edward Suh, MD Lifespan
Publications:
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Responsible Party: Edward Suh, Principal Investigator; Clinical Instructor, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03902314    
Other Study ID Numbers: 014118
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Edward Suh, Rhode Island Hospital:
Lidocaine
Tonsillectomy and Adenoidectomy
Pain
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action