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

Study Description

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.

Study Design

• 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: July 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Edward I Suh, MD; 401-444-5172; esuh@lifespan.org

Contact: Mark Kendall, MD; 401-444-4933; mark.kendall@lifespan.org

Locations

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

• Principal Investigator: Edward Suh, MD; Lifespan

More Information

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.

• Responsible Party: Edward Suh MD, Principal Investigator; Clinical Instructor, Rhode Island Hospital
• ClinicalTrials.gov Identifier: NCT03902314
• Other Study ID Numbers: 014118
• First Posted: April 4, 2019
• Last Update Posted: October 30, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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 MD, Rhode Island Hospital:

Lidocaine; Tonsillectomy and Adenoidectomy; Pain

Additional relevant MeSH terms:

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