Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

NCT02595463 | Completed Phase 2

• 1 other identifier: 2015-741
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Observer Rated Pain Intensity

  Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.

  Within the immediate post-operative period (90 minutes after surgery)

Secondary Outcomes (5)

• Patient Rated Pain Intensity

  Within the immediate post-operative period (90 minutes after surgery)

• Observer Rated Emergence Delirium

  Within the immediate post-operative period (90 minutes after surgery)

• Observer Rated PACU Discharge Criteria

  Within the immediate post-operative period (90 minutes after surgery)

• Parent Rated Postoperative Pain at Home

  Every day, up to 7 days postoperatively

• Medication Journal

  Every day, up to 7 days postoperatively

Study Arms (2)

Lidocaine

EXPERIMENTAL

Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period.

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm.

Drug: Saline

Interventions

Lidocaine DRUG

Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.

Also known as: Xylocaine, Lidocaine Hydrochloride

Lidocaine

Saline DRUG

Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• 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.

  PMID: 26184397 BACKGROUND

• 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.

  PMID: 10692621 BACKGROUND

• 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.

  PMID: 23595509 BACKGROUND

• 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.

  PMID: 20518581 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hubert Benzon, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: June 5, 2024
• Study Completion: July 5, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)