Trial Outcomes & Findings for Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial (NCT NCT02218203)
NCT ID: NCT02218203
Last Updated: 2025-12-08
Results Overview
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
30 minutes post-infusion (Cmax)
Results posted on
2025-12-08
Participant Flow
Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.
During the screening visit, P450 2D6 phenotype status was determined for each subject to identify dextromethorphan-metabolizing capacity; those who were P450 2D6 poor-metabolizers were excluded. Following screen, subjects entered a dose escalation study to determine their maximum tolerated dose of dextromethorphan, prior to randomization.
Participant milestones
| Measure |
Dextromethorphan/Lidocaine Combination Clinical Trial
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Placebo Dex v. 0mg/km LBM Lidocaine
|
24
|
|
Overall Study
Placebo Dex v. 1mg/km LBM Lidocaine
|
24
|
|
Overall Study
Placebo Dex v. 2mg/km LBM Lidocaine
|
24
|
|
Overall Study
Placebo Dex v. 4mg/km LBM Lidocaine
|
24
|
|
Overall Study
Low Dose Dex v. 0mg/km LBM Lidocaine
|
26
|
|
Overall Study
Low Dose Dex v. 1mg/km LBM Lidocaine
|
26
|
|
Overall Study
Low Dose Dex v. 2mg/km LBM Lidocaine
|
26
|
|
Overall Study
Low Dose Dex v. 4mg/km LBM Lidocaine
|
26
|
|
Overall Study
Medium Dose Dex v. 0mg/km LBM Lidocaine
|
24
|
|
Overall Study
Medium Dose Dex v. 1mg/km LBM Lidocaine
|
24
|
|
Overall Study
Medium Dose Dex v. 2mg/km LBM Lidocaine
|
24
|
|
Overall Study
Medium Dose Dex v. 4mg/km LBM Lidocaine
|
24
|
|
Overall Study
High Dose Dex v. 0mg/km LBM Lidocaine
|
24
|
|
Overall Study
High Dose Dex v. 1mg/km LBM Lidocaine
|
24
|
|
Overall Study
High Dose Dex v. 2mg/km LBM Lidocaine
|
24
|
|
Overall Study
High Dose Dex v. 4mg/km LBM Lidocaine
|
24
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Baseline characteristics by cohort
| Measure |
Dextromethorphan/Lidocaine Combination Clinical Trial
n=26 Participants
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=37 Participants
|
|
Age, Continuous
|
46.84 years
STANDARD_DEVIATION 11.32 • n=37 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=37 Participants
|
|
Region of Enrollment
North America
|
26 participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-infusion (Cmax)Population: Central neuropathic pain following SCI; we present the primary efficacy endpoint (percent change in peak pain intensity) of this nested IV lidocaine dose-response clinical trial independent of the dextromethorphan doses, because the distribution of the dextromethorphan doses is balanced across the lidocaine treatment arms.
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
Outcome measures
| Measure |
Dextromethorphan/ 0mg/kg Lidocaine Combination
n=26 Participants
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 0mg/kg Lidocaine.
|
Dextromethorphan/1mg/kg Lidocaine Combination
n=26 Participants
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 1mg/kg Lidocaine.
|
Dextromethorphan/2mg/kg Lidocaine Combination
n=26 Participants
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 2mg/kg Lidocaine.
|
Dextromethorphan/4mg/kg Lidocaine Combination
n=26 Participants
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury. This arm represents an average of all dextromethorphan doses in combination with 4mg/kg Lidocaine.
|
|---|---|---|---|---|
|
Percent Change in Peak Pain Intensity
|
-2.5 percentage change from baseline
Standard Error 0.0049
|
-7.9 percentage change from baseline
Standard Error 0.0176
|
-11.2 percentage change from baseline
Standard Error 0.0015
|
-19.2 percentage change from baseline
Standard Error 0.0226
|
Adverse Events
Placebo Dextromethorphan/0mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Dextromethorphan/1mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Dextromethorphan/2mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Dextromethorphan/4mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Low Dose Dextromethorphan/0mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Low Dose Dextromethorphan/1mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Low Dose Dextromethorphan/2mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Low Dose Dextromethorphan/4mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
High Dose Dextromethorphan/0mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose Dextromethorphan/1mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose Dextromethorphan/2mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Dextromethorphan/0mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Placebo Dextromethorphan/1mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Placebo Dextromethorphan/2mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Placebo Dextromethorphan/4mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Low Dose Dextromethorphan/0mg/kg Lidocaine Combination
n=26 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Low Dose Dextromethorphan/1mg/kg Lidocaine Combination
n=26 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Low Dose Dextromethorphan/2mg/kg Lidocaine Combination
n=26 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Low Dose Dextromethorphan/4mg/kg Lidocaine Combination
n=26 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
High Dose Dextromethorphan/0mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
High Dose Dextromethorphan/1mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
High Dose Dextromethorphan/2mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
High Dose Dextromethorphan/4mg/kg Lidocaine Combination
n=24 participants at risk
This randomized, placebo-controlled, double-blind 4x4 factorial crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO)dextromethorphan (placebo, low dose, medium dose, and high dose) and intravenous (IV) lidocaine (0mg/kg LBM, 1mg/kg LBM, 2mg/kg LBM, and 4mg/kg LBM) in central neuropathic pain following spinal cord injury.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Sedation Complex
|
12.5%
3/24 • Number of events 5 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
12.5%
3/24 • Number of events 7 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
20.8%
5/24 • Number of events 7 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
29.2%
7/24 • Number of events 15 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
19.2%
5/26 • Number of events 7 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
26.9%
7/26 • Number of events 10 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
26.9%
7/26 • Number of events 16 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
53.8%
14/26 • Number of events 36 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
12.5%
3/24 • Number of events 6 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
20.8%
5/24 • Number of events 12 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
16.7%
4/24 • Number of events 8 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
58.3%
14/24 • Number of events 28 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
12.5%
3/24 • Number of events 6 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
25.0%
6/24 • Number of events 14 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
66.7%
16/24 • Number of events 38 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
|
Nervous system disorders
Dry mouth
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
7.7%
2/26 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
7.7%
2/26 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
7.7%
2/26 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
19.2%
5/26 • Number of events 5 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
16.7%
4/24 • Number of events 4 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
|
Nervous system disorders
Euphoria
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
7.7%
2/26 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
|
Nervous system disorders
Parathesias
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
16.7%
4/24 • Number of events 5 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
7.7%
2/26 • Number of events 3 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
11.5%
3/26 • Number of events 4 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
19.2%
5/26 • Number of events 8 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
29.2%
7/24 • Number of events 8 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 3 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
29.2%
7/24 • Number of events 10 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
|
Musculoskeletal and connective tissue disorders
Cramping/Spasms
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/26 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 3 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
0.00%
0/24 • Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30)
|
Additional Information
Christine N. Sang, MD, MPH
Translational Pain Research, Brigham and Women's Hospital
Phone: 617-525-7246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place