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Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

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ClinicalTrials.gov Identifier: NCT02218203
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Central Neuropathic Pain
Allodynia
Spinal Cord Injury
Interventions Drug: Dextromethorphan
Drug: Lidocaine
Drug: Placebo (Dextromethorphan)
Drug: Placebo (Lidocaine)
Enrollment 26
Recruitment Details Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.
Pre-assignment Details 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.
Arm/Group Title Dextromethorphan/Lidocaine Combination Clinical Trial
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 26
Placebo Dex v. 0mg/km LBM Lidocaine 24
Placebo Dex v. 1mg/km LBM Lidocaine 24
Placebo Dex v. 2mg/km LBM Lidocaine 24
Placebo Dex v. 4mg/km LBM Lidocaine 24
Low Dose Dex v. 0mg/km LBM Lidocaine 26
Low Dose Dex v. 1mg/km LBM Lidocaine 26
Low Dose Dex v. 2mg/km LBM Lidocaine 26
Low Dose Dex v. 4mg/km LBM Lidocaine 26
Medium Dose Dex v. 0mg/km LBM Lidocaine 24
Medium Dose Dex v. 1mg/km LBM Lidocaine 24
Medium Dose Dex v. 2mg/km LBM Lidocaine 24
Medium Dose Dex v. 4mg/km LBM Lidocaine 24
High Dose Dex v. 0mg/km LBM Lidocaine 24
High Dose Dex v. 1mg/km LBM Lidocaine 24
High Dose Dex v. 2mg/km LBM Lidocaine 24
High Dose Dex v. 4mg/km LBM Lidocaine 24
Completed 26 [1]
Not Completed 0
[1]
2 subjects did not complete the placebo, medium dose, and high dose dex/lido combination arms.
Arm/Group Title Dextromethorphan/Lidocaine Combination Clinical Trial
Hide Arm/Group Description 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 Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  96.2%
>=65 years
1
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
46.84  (11.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
14
  53.8%
Male
12
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 26 participants
26
1.Primary Outcome
Title Percent Change in Peak Pain Intensity
Hide Description 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.
Time Frame 30 minutes post-infusion (Cmax)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dextromethorphan/ 0mg/kg Lidocaine Combination Dextromethorphan/1mg/kg Lidocaine Combination Dextromethorphan/2mg/kg Lidocaine Combination Dextromethorphan/4mg/kg Lidocaine Combination
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 26 26 26 26
Mean (Standard Error)
Unit of Measure: percentage change from baseline
-2.5  (0.0049) -7.9  (0.0176) -11.2  (0.0015) -19.2  (0.0226)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dextromethorphan/ 0mg/kg Lidocaine Combination, Dextromethorphan/1mg/kg Lidocaine Combination, Dextromethorphan/2mg/kg Lidocaine Combination, Dextromethorphan/4mg/kg Lidocaine Combination
Comments We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).
Type of Statistical Test Other
Comments We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.
Statistical Test of Hypothesis P-Value 0.0322
Comments [Not Specified]
Method Pearson’s Chi-squared test
Comments [Not Specified]
Method of Estimation Estimation Parameter Lidocaine dose*dextromethorphan dose
Estimated Value 0.0042
Confidence Interval (2-Sided) 95%
0.0004 to 0.0081
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0020
Estimation Comments The estimated value is an estimated interaction term, and not a P-value.
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dextromethorphan/0mg/kg Lidocaine Combination Placebo Dextromethorphan/1mg/kg Lidocaine Combination Placebo Dextromethorphan/2mg/kg Lidocaine Combination Placebo Dextromethorphan/4mg/kg Lidocaine Combination Low Dose Dextromethorphan/0mg/kg Lidocaine Combination Low Dose Dextromethorphan/1mg/kg Lidocaine Combination Low Dose Dextromethorphan/2mg/kg Lidocaine Combination Low Dose Dextromethorphan/4mg/kg Lidocaine Combination Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination High Dose Dextromethorphan/0mg/kg Lidocaine Combination High Dose Dextromethorphan/1mg/kg Lidocaine Combination High Dose Dextromethorphan/2mg/kg Lidocaine Combination High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Hide Arm/Group Description 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
All-Cause Mortality
Placebo Dextromethorphan/0mg/kg Lidocaine Combination Placebo Dextromethorphan/1mg/kg Lidocaine Combination Placebo Dextromethorphan/2mg/kg Lidocaine Combination Placebo Dextromethorphan/4mg/kg Lidocaine Combination Low Dose Dextromethorphan/0mg/kg Lidocaine Combination Low Dose Dextromethorphan/1mg/kg Lidocaine Combination Low Dose Dextromethorphan/2mg/kg Lidocaine Combination Low Dose Dextromethorphan/4mg/kg Lidocaine Combination Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination High Dose Dextromethorphan/0mg/kg Lidocaine Combination High Dose Dextromethorphan/1mg/kg Lidocaine Combination High Dose Dextromethorphan/2mg/kg Lidocaine Combination High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dextromethorphan/0mg/kg Lidocaine Combination Placebo Dextromethorphan/1mg/kg Lidocaine Combination Placebo Dextromethorphan/2mg/kg Lidocaine Combination Placebo Dextromethorphan/4mg/kg Lidocaine Combination Low Dose Dextromethorphan/0mg/kg Lidocaine Combination Low Dose Dextromethorphan/1mg/kg Lidocaine Combination Low Dose Dextromethorphan/2mg/kg Lidocaine Combination Low Dose Dextromethorphan/4mg/kg Lidocaine Combination Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination High Dose Dextromethorphan/0mg/kg Lidocaine Combination High Dose Dextromethorphan/1mg/kg Lidocaine Combination High Dose Dextromethorphan/2mg/kg Lidocaine Combination High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/26 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dextromethorphan/0mg/kg Lidocaine Combination Placebo Dextromethorphan/1mg/kg Lidocaine Combination Placebo Dextromethorphan/2mg/kg Lidocaine Combination Placebo Dextromethorphan/4mg/kg Lidocaine Combination Low Dose Dextromethorphan/0mg/kg Lidocaine Combination Low Dose Dextromethorphan/1mg/kg Lidocaine Combination Low Dose Dextromethorphan/2mg/kg Lidocaine Combination Low Dose Dextromethorphan/4mg/kg Lidocaine Combination Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination High Dose Dextromethorphan/0mg/kg Lidocaine Combination High Dose Dextromethorphan/1mg/kg Lidocaine Combination High Dose Dextromethorphan/2mg/kg Lidocaine Combination High Dose Dextromethorphan/4mg/kg Lidocaine Combination
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      3/24 (12.50%)      5/24 (20.83%)      10/24 (41.67%)      5/26 (19.23%)      7/26 (26.92%)      8/26 (30.77%)      15/26 (57.69%)      3/24 (12.50%)      6/24 (25.00%)      6/24 (25.00%)      15/24 (62.50%)      3/24 (12.50%)      3/24 (12.50%)      6/24 (25.00%)      17/24 (70.83%)    
Musculoskeletal and connective tissue disorders                                 
Cramping/Spasms  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  3 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders                                 
Sedation Complex [1]  3/24 (12.50%)  5 3/24 (12.50%)  7 5/24 (20.83%)  7 7/24 (29.17%)  15 5/26 (19.23%)  7 7/26 (26.92%)  10 7/26 (26.92%)  16 14/26 (53.85%)  36 3/24 (12.50%)  6 5/24 (20.83%)  12 4/24 (16.67%)  8 14/24 (58.33%)  28 3/24 (12.50%)  6 2/24 (8.33%)  2 6/24 (25.00%)  14 16/24 (66.67%)  38
Dry mouth  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 2/26 (7.69%)  2 2/26 (7.69%)  2 2/26 (7.69%)  2 5/26 (19.23%)  5 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  3 2/24 (8.33%)  2 0/24 (0.00%)  0 2/24 (8.33%)  2 4/24 (16.67%)  4
Euphoria  1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0 0/26 (0.00%)  0 2/26 (7.69%)  2 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1 1/24 (4.17%)  1 2/24 (8.33%)  2
Parathesias [2]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 4/24 (16.67%)  5 0/26 (0.00%)  0 2/26 (7.69%)  3 3/26 (11.54%)  4 5/26 (19.23%)  8 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 7/24 (29.17%)  8 0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  3 7/24 (29.17%)  10
[1]
Dizziness, blurry vision, interference with ability to drive/alertness, etc.
[2]
Numbness, tingling, burning
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine N. Sang, MD, MPH
Organization: Translational Pain Research, Brigham and Women's Hospital
Phone: 617-525-7246
EMail: paintrials@partners.org
Layout table for additonal information
Responsible Party: Christine N. Sang, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02218203     History of Changes
Other Study ID Numbers: RO1NS41503-2
First Submitted: August 13, 2014
First Posted: August 18, 2014
Results First Submitted: March 29, 2017
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018