Trial Outcomes & Findings for IV Lidocaine in Pediatric AIS (NCT NCT03893318)

NCT ID: NCT03893318

Last Updated: 2025-11-12

Results Overview

measured in morphine-equivalent dosage (MED)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: up to 6 weeks after surgery
• Results posted on: 2025-11-12

Participant Flow

Participant milestones

Measure	Study Group will receive intravenous lidocaine during and after posterior spinal fusion for AIS IV lidocaine: an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.	Control Group will receive saline placebo during and after surgery. Placebos: Saline
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total n=15 Participants Total of all reporting groups	Study Group n=8 Participants will receive intravenous lidocaine during and after posterior spinal fusion for AIS IV lidocaine: an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.	Control Group n=7 Participants will receive saline placebo during and after surgery. Placebos: Saline
Age, Categorical <=18 years	15 Participants n=15 Participants	8 Participants n=8 Participants	7 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants
Age, Continuous	13.9 Years n=15 Participants	13.5 Years n=8 Participants	14.4 Years n=7 Participants
Sex: Female, Male Female	12 Participants n=15 Participants	7 Participants n=8 Participants	5 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=15 Participants	1 Participants n=8 Participants	2 Participants n=7 Participants
Race and Ethnicity Not Collected	0 Participants Race and Ethnicity were not collected from any participant.	—	—
Region of Enrollment United States	15 Participants n=15 Participants	8 Participants n=8 Participants	7 Participants n=7 Participants
BMI	23.1 kg/m^2 n=15 Participants	22.8 kg/m^2 n=8 Participants	23.4 kg/m^2 n=7 Participants

PRIMARY outcome

Timeframe: up to 6 weeks after surgery

measured in morphine-equivalent dosage (MED)

Outcome measures

Measure	Study n=8 Participants Lidocaine: Will receive intravenous lidocaine during and after posterior spinal fusion for AIS	Control n=7 Participants Control: Will receive saline placebo during and after surgery
Opioid Consumption	63.7 Morphine ME Interval 41.3 to 105.3	119.3 Morphine ME Interval 38.1 to 180.1

Adverse Events

Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Kelly, MD

University of California, San Diego

Phone: 508-410-9567

Email: mpkelly@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place