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

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

Tracking Information

• First Submitted Date: March 27, 2019
• First Posted Date: April 4, 2019
• Last Update Posted Date: October 30, 2020
• Actual Study Start Date: May 7, 2019
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy
• Official Title: 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: Interventional
• Study Phase: Phase 4

Study Design

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

• Children, Only
• Tonsillar Hypertrophy
• Adenoid Hypertrophy

Intervention

• Drug: Lidocaine Iv
  Intravenous infusion
• Drug: Saline Solution
  Intravenous infusion

Study Arms

• 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 *

• Guntinas-Lichius O, Volk GF, Geissler K, Komann M, Meissner W. Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2049-60. doi: 10.1007/s00405-014-2914-9. Epub 2014 Feb 9.
• Howard D, Davis KF, Phillips E, Ryan E, Scalford D, Flynn-Roth R, Ely E. Pain management for pediatric tonsillectomy: an integrative review through the perioperative and home experience. J Spec Pediatr Nurs. 2014 Jan;19(1):5-16. doi: 10.1111/jspn.12048. Epub 2013 Aug 21. Review.
• 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.
• Vigneault L, Turgeon AF, Côté D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. Review.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 2, 2019): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 10 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

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: United States

Administrative Information

• NCT Number: NCT03902314
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Edward Suh MD, Rhode Island Hospital
• Study Sponsor: Rhode Island Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Edward Suh, MD; Lifespan

• PRS Account: Rhode Island Hospital
• Verification Date: October 2020