Clinical trial NCT03902314: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Children, Only
Tonsillar Hypertrophy
Adenoid Hypertrophy
Keywords: Lidocaine
Tonsillectomy and Adenoidectomy
Pain
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pain Scores
timeFrame: 15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.
Secondary outcomes:
measure: Opioid consumption
timeFrame: Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)
measure: Emergence delirium scores
timeFrame: 5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery
measure: Parental satisfaction with the anesthetic
timeFrame: Evaluated once on postoperative day 1 (or 24 hours after surgery)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Lifespan
name: Edward Suh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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: 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.