Clinical trial NCT02595463: Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients
Official title: Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 89
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

Detailed description: The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.

Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Eligibility criteria: Inclusion Criteria:

* Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
* American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)

Exclusion Criteria:

* Physical or developmental delays
* Psychiatric illness
* Current use of sedative or anticonvulsant medications
* Pre-existing renal disease (ranging from stage 2 \[mild\] to stage 5 \[end stage\])
* Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
* Pre-existing liver disease
* Pre-existing cerebral or neuromuscular disease
* Patient or family history of Malignant Hyperthermia
* Recent history of upper respiratory infection within last 7 days
* Regular use of analgesic medication
* Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
* Other procedure scheduled in addition to tonsillectomy
* History of allergies to local anesthetics

Primary outcomes:
measure: Observer Rated Pain Intensity
timeFrame: Within the immediate post-operative period (90 minutes after surgery)
Secondary outcomes:
measure: Patient Rated Pain Intensity
timeFrame: Within the immediate post-operative period (90 minutes after surgery)
measure: Observer Rated Emergence Delirium
timeFrame: Within the immediate post-operative period (90 minutes after surgery)
measure: Observer Rated PACU Discharge Criteria
timeFrame: Within the immediate post-operative period (90 minutes after surgery)
measure: Parent Rated Postoperative Pain at Home
timeFrame: Every day, up to 7 days postoperatively
measure: Medication Journal
timeFrame: Every day, up to 7 days postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Hubert Benzon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
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.
citation: Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. doi: 10.1002/lary.23926. Epub 2013 Apr 17.
citation: McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.