Adenoid Hypertrophy, Children, Only, Tonsillar Hypertrophy
Conditions
Keywords
Lidocaine, Tonsillectomy and Adenoidectomy, Pain
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.
Interventions
DRUGLidocaine Iv
Intravenous infusion
DRUGSaline Solution
Intravenous infusion
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, 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.
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
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 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 | 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 | 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 |
Countries
United States
Outcome results
None listed