NCT02595463

Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Lidocaine	Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
DRUG	Saline	Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Timeline

• Start date: 2015-11-01
• Primary completion: 2024-06-05
• Completion: 2024-07-05
• First posted: 2015-11-03
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States