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Trial record 20 of 74 for:    Codeine AND Acetaminophen

Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01402375
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Analgesia After ED Discharge for Extremity Injuries
Interventions Drug: Hydrocodone (first trial)
Drug: Codeine (first trial)
Drug: Oxycodone (for second trial)
Drug: Codeine (for second trial)
Drug: Oxycodone (third trial)
Drug: Hydrocodone (third trial)
Enrollment 720
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Period Title: Overall Study
Started 120 120 120 120 120 120
Completed 120 120 120 120 120 120
Not Completed 0 0 0 0 0 0
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial) Total
Hide Arm/Group Description

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Total of all reporting groups
Overall Number of Baseline Participants 88 93 111 104 107 113 616
Hide Baseline Analysis Population Description
Patients excluded from data analysis: First trial - patients did not take study medication Second trial - 7 patients unable to be reached for follow up, 18 did not take study medication Third trial - 5 patients unable to be reached for follow up, 15 did not take study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
34  (12) 37  (11) 39  (12) 38  (11) 39  (12) 38  (13) 38  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
Female
38
  43.2%
48
  51.6%
62
  55.9%
58
  55.8%
60
  56.1%
48
  42.5%
314
  51.0%
Male
50
  56.8%
45
  48.4%
49
  44.1%
46
  44.2%
47
  43.9%
65
  57.5%
302
  49.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
Hispanic
56
  63.6%
69
  74.2%
66
  59.5%
71
  68.3%
67
  62.6%
73
  64.6%
402
  65.3%
African American
27
  30.7%
18
  19.4%
35
  31.5%
27
  26.0%
32
  29.9%
28
  24.8%
167
  27.1%
Other
5
   5.7%
6
   6.5%
10
   9.0%
6
   5.8%
8
   7.5%
12
  10.6%
47
   7.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
88
 100.0%
93
 100.0%
111
 100.0%
104
 100.0%
107
 100.0%
113
 100.0%
616
 100.0%
NRS pain intensity score on ED arrival   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
9
(8 to 10)
9
(8 to 10)
10
(8 to 10)
10
(8 to 10)
10
(8 to 10)
10
(8 to 10)
10
(8 to 10)
[1]
Measure Description: Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable")
NRS pain intensity score on discharge   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
7
(5 to 8)
7
(5 to 8)
7
(6 to 9)
7
(5 to 9)
8
(6 to 9)
8
(6 to 9)
7
(5 to 9)
[1]
Measure Description:

Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable").

The study involved patients taking study medications AFTER emergency department discharge, and the primary outcome also involved NRS pain scores 24 hours AFTER ED discharge. Thus, any data collected while in the ED is considered baseline.

Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
Sprain/strain
40
  45.5%
54
  58.1%
59
  53.2%
49
  47.1%
39
  36.4%
42
  37.2%
283
  45.9%
Extremity Fracture
20
  22.7%
17
  18.3%
33
  29.7%
37
  35.6%
63
  58.9%
58
  51.3%
228
  37.0%
Other
28
  31.8%
22
  23.7%
19
  17.1%
18
  17.3%
5
   4.7%
13
  11.5%
105
  17.0%
Took analgesic prior to presentation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 93 participants 111 participants 104 participants 107 participants 113 participants 616 participants
No
63
  71.6%
63
  67.7%
72
  64.9%
70
  67.3%
76
  71.0%
74
  65.5%
418
  67.9%
Yes
24
  27.3%
27
  29.0%
37
  33.3%
33
  31.7%
29
  27.1%
36
  31.9%
186
  30.2%
Unknown
1
   1.1%
3
   3.2%
2
   1.8%
1
   1.0%
2
   1.9%
3
   2.7%
12
   1.9%
1.Primary Outcome
Title Difference in Pain Intensity Score Before and After Last Dose.
Hide Description Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken.
Time Frame 2 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description:

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Overall Number of Participants Analyzed 88 93 111 104 107 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
before most recent dose 7.6  (1.7) 7.6  (1.8) 7.9  (1.5) 7.9  (1.7) 7.8  (1.5) 7.6  (1.6)
2 hours after most recent dose 3.6  (2.8) 4.1  (2.9) 3.4  (2.5) 3.6  (4.2) 3.3  (2.7) 3.6  (2.6)
change in NRS before to after most recent dose 3.9  (2.5) 3.5  (2.6) 4.5  (2.4) 4.2  (2.4) 4.4  (2.5) 4.0  (2.5)
2.Secondary Outcome
Title Overall Satisfaction With the Pain Medicine
Hide Description Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication.
Time Frame 24 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Any number analyzed that does not equal the overall number of participants is due to missing data
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description:

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Overall Number of Participants Analyzed 88 93 111 104 107 113
Measure Type: Count of Participants
Unit of Measure: Participants
Number of participants satisfied with analgesic Number Analyzed 87 participants 93 participants 111 participants 104 participants 107 participants 113 participants
72
  82.8%
66
  71.0%
99
  89.2%
91
  87.5%
93
  86.9%
97
  85.8%
participants would want the same analgesic again Number Analyzed 85 participants 93 participants 111 participants 104 participants 107 participants 113 participants
59
  69.4%
66
  71.0%
91
  82.0%
85
  81.7%
86
  80.4%
90
  79.6%
3.Post-Hoc Outcome
Title 50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description:

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Overall Number of Participants Analyzed 88 93 111 104 107 113
Measure Type: Count of Participants
Unit of Measure: Participants
50
  56.8%
45
  48.4%
73
  65.8%
64
  61.5%
68
  63.6%
66
  58.4%
4.Post-Hoc Outcome
Title Time to Follow up
Hide Description Median time to contact patients for data collection, measured from discharge to time contacted
Time Frame up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description:

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

Overall Number of Participants Analyzed 88 93 111 104 107 113
Median (Inter-Quartile Range)
Unit of Measure: hours
27
(24 to 42)
25
(24 to 36)
26
(24 to 37)
28
(25 to 36)
27
(25 to 42)
28
(25 to 41)
Time Frame follow up period, 24-48 hours
Adverse Event Reporting Description In adverse events, any change in total participants at risk from overall number reflects missing data
 
Arm/Group Title Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Hide Arm/Group Description

Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain

Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain

Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain

Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.

All-Cause Mortality
Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/88 (0.00%)   0/93 (0.00%)   0/111 (0.00%)   0/104 (0.00%)   0/107 (0.00%)   0/113 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/88 (0.00%)   0/93 (0.00%)   0/111 (0.00%)   0/104 (0.00%)   0/107 (0.00%)   0/113 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydrocodone (First Trial) Codeine (First Trial) Oxycodone (for Second Trial) Codeine (for Second Trial) Oxycodone (Third Trial) Hydrocodone (Third Trial)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/88 (61.36%)   51/93 (54.84%)   68/111 (61.26%)   61/104 (58.65%)   74/106 (69.81%)   51/112 (45.54%) 
Gastrointestinal disorders             
Nausea  9/87 (10.34%)  9/92 (9.78%)  13/111 (11.71%)  12/104 (11.54%)  18/105 (17.14%)  8/112 (7.14%) 
Vomiting  2/87 (2.30%)  1/92 (1.09%)  4/111 (3.60%)  2/104 (1.92%)  5/105 (4.76%)  1/112 (0.89%) 
Constipation  0/88 (0.00%)  0/93 (0.00%)  0/111 (0.00%)  0/104 (0.00%)  0/106 (0.00%)  2/110 (1.82%) 
Diarrhea  0/87 (0.00%)  5/93 (5.38%)  1/111 (0.90%)  3/104 (2.88%)  3/106 (2.83%)  2/110 (1.82%) 
Nervous system disorders             
Dizziness  12/87 (13.79%)  5/93 (5.38%)  11/111 (9.91%)  13/104 (12.50%)  18/106 (16.98%)  8/111 (7.21%) 
Drowsiness  25/88 (28.41%)  27/93 (29.03%)  30/111 (27.03%)  23/104 (22.12%)  24/105 (22.86%)  23/112 (20.54%) 
Confusion  2/86 (2.33%)  1/93 (1.08%)  1/111 (0.90%)  1/104 (0.96%)  1/104 (0.96%)  1/109 (0.92%) 
Skin and subcutaneous tissue disorders             
Pruritus  3/87 (3.45%)  3/93 (3.23%)  6/111 (5.41%)  4/104 (3.85%)  3/106 (2.83%)  4/110 (3.64%) 
Rash  1/87 (1.15%)  0/92 (0.00%)  2/111 (1.80%)  3/104 (2.88%)  2/106 (1.89%)  2/111 (1.80%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Chang, MD, MS
Organization: Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center
Phone: 718-920-6626
EMail: achang3@yahoo.com
Layout table for additonal information
Responsible Party: Andrew Chang, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01402375     History of Changes
Other Study ID Numbers: 11-02-066
First Submitted: July 24, 2011
First Posted: July 26, 2011
Results First Submitted: March 1, 2018
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018