Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT02595463
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2024-06-05
• Study Completion: 2024-07-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	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.
Lidocaine	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Observer Rated Pain Intensity	Within the immediate post-operative period (90 minutes after surgery)	Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.

Secondary Outcome Measures

Name	Time	Method
Observer Rated Emergence Delirium	Within the immediate post-operative period (90 minutes after surgery)	Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.
Observer Rated PACU Discharge Criteria	Within the immediate post-operative period (90 minutes after surgery)	Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals.
Patient Rated Pain Intensity	Within the immediate post-operative period (90 minutes after surgery)	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.
Parent Rated Postoperative Pain at Home	Every day, up to 7 days postoperatively	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.
Medication Journal	Every day, up to 7 days postoperatively	Parents will keep a journal of all pain medication given to their children to treat pain.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States