Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Pain Clinical Trial

Official title:

Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595463
• Other study ID #: 2015-741
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2015
• Est. completion date: May 2022

Study information

• Verified date: August 2021
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: John Hajduk
• Phone: 312-227-5295
• Email: jhajduk[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
• Saline
Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009642. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Rated Pain Intensity	Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals.	Within the immediate post-operative period (90 minutes after surgery)
Secondary	Observer Rated Emergence Delirium	Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.	Within the immediate post-operative period (90 minutes after surgery)
Secondary	Observer Rated PACU Discharge Criteria	Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals.	Within the immediate post-operative period (90 minutes after surgery)
Secondary	Parent Rated Postoperative Pain at Home	Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain.	Every day, up to 7 days postoperatively
Secondary	Medication Journal	Parents will keep a journal of all pain medication given to their children to treat pain.	Every day, up to 7 days postoperatively