Back to resultsLidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy
Primary Purpose
Children, Only, Tonsillar Hypertrophy, Adenoid Hypertrophy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Iv
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Children, Only focused on measuring Lidocaine, Tonsillectomy and Adenoidectomy, Pain
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
Sites / Locations
- Hasbro Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine
Saline
Arm Description
Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Outcomes
Primary Outcome Measures
Change in Pain Scores
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
Opioid consumption
Morphine equivalents
Emergence delirium scores
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
Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better
Full Information
NCT ID
NCT03902314
First Posted
March 27, 2019
Last Updated
December 20, 2021
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03902314
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Only, Tonsillar Hypertrophy, Adenoid Hypertrophy
Keywords
Lidocaine, Tonsillectomy and Adenoidectomy, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Change in Pain Scores
Description
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.
Time Frame
15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Morphine equivalents
Time Frame
Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)
Title
Emergence delirium scores
Description
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.
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
Title
Parental satisfaction with the anesthetic
Description
Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better
Time Frame
Evaluated once on postoperative day 1 (or 24 hours after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Suh, MD
Organizational Affiliation
Lifespan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24510234
Citation
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.
Results Reference
background
PubMed Identifier
24393224
Citation
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.
Results Reference
background
PubMed Identifier
10692621
Citation
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.
Results Reference
background
PubMed Identifier
21061107
Citation
Vigneault L, Turgeon AF, Cote 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.
Results Reference
background
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Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy
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