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

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ClinicalTrials.gov Identifier: NCT03902314
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Edward Suh MD, Rhode Island Hospital

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
Change in Pain 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 ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy
Official Title  ICMJE Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Children, Only
  • Tonsillar Hypertrophy
  • Adenoid Hypertrophy
Intervention  ICMJE
  • Drug: Lidocaine Iv
    Intravenous infusion
  • Drug: Saline Solution
    Intravenous infusion
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lidocaine Iv
  • 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.
    Intervention: Drug: Saline Solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edward I Suh, MD 401-444-5172 esuh@lifespan.org
Contact: Mark Kendall, MD 401-444-4933 mark.kendall@lifespan.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03902314
Other Study ID Numbers  ICMJE 014118
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edward Suh MD, Rhode Island Hospital
Study Sponsor  ICMJE Rhode Island Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Suh, MD Lifespan
PRS Account Rhode Island Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP