Trial Outcomes & Findings for Dexamethasone and Pain Following Total Knee Arthroplasty (NCT NCT02271698)
NCT ID: NCT02271698
Last Updated: 2018-02-20
Results Overview
Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
6, 12, 18, 24, 36 hours after surgery
Results posted on
2018-02-20
Participant Flow
45 participants signed consent. 3 participants withdrew prior to randomization
Participant milestones
| Measure |
Dexamethasone 6mg
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone and Pain Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=10 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=11 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.06 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
66.56 years
STANDARD_DEVIATION 8.32 • n=7 Participants
|
64.14 years
STANDARD_DEVIATION 6.43 • n=5 Participants
|
69.45 years
STANDARD_DEVIATION 5.45 • n=4 Participants
|
67.13 years
STANDARD_DEVIATION 7.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 36 hours after surgeryPopulation: Participants who completed pain score at specified time-points.
Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever.
Outcome measures
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=9 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=11 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Change in Visual Analogue Pain Score
6 hour at rest
|
3.09 units on a scale
Standard Deviation 1.45
|
4.80 units on a scale
Standard Deviation 2.20
|
3.56 units on a scale
Standard Deviation 2.74
|
5.5 units on a scale
Standard Deviation 2.54
|
|
Change in Visual Analogue Pain Score
6 hour with movement
|
4.36 units on a scale
Standard Deviation 2.42
|
6.50 units on a scale
Standard Deviation 3.10
|
5.88 units on a scale
Standard Deviation 2.47
|
7.33 units on a scale
Standard Deviation 1.80
|
|
Change in Visual Analogue Pain Score
12 hour at rest
|
2.82 units on a scale
Standard Deviation 1.99
|
3.50 units on a scale
Standard Deviation 1.96
|
2.78 units on a scale
Standard Deviation 1.86
|
5.18 units on a scale
Standard Deviation 2.99
|
|
Change in Visual Analogue Pain Score
12 hour with movement
|
5.75 units on a scale
Standard Deviation 2.25
|
6.11 units on a scale
Standard Deviation 1.76
|
6.00 units on a scale
Standard Deviation 2.77
|
7.30 units on a scale
Standard Deviation 3.23
|
|
Change in Visual Analogue Pain Score
18 hour at rest
|
1.55 units on a scale
Standard Deviation 1.86
|
2.70 units on a scale
Standard Deviation 2.45
|
2.56 units on a scale
Standard Deviation 2.40
|
5.09 units on a scale
Standard Deviation 2.39
|
|
Change in Visual Analogue Pain Score
18 hour with movement
|
4.00 units on a scale
Standard Deviation 3.16
|
5.43 units on a scale
Standard Deviation 2.99
|
4.63 units on a scale
Standard Deviation 2.88
|
6.90 units on a scale
Standard Deviation 3.00
|
|
Change in Visual Analogue Pain Score
24 hour at rest
|
2.91 units on a scale
Standard Deviation 2.34
|
3.50 units on a scale
Standard Deviation 2.27
|
3.67 units on a scale
Standard Deviation 2.65
|
4.09 units on a scale
Standard Deviation 2.84
|
|
Change in Visual Analogue Pain Score
24 hour with movement
|
4.82 units on a scale
Standard Deviation 2.68
|
6.50 units on a scale
Standard Deviation 2.07
|
6.38 units on a scale
Standard Deviation 2.33
|
7.20 units on a scale
Standard Deviation 2.15
|
|
Change in Visual Analogue Pain Score
36 hour at rest
|
3.00 units on a scale
Standard Deviation 2.24
|
3.86 units on a scale
Standard Deviation 2.54
|
4.43 units on a scale
Standard Deviation 2.30
|
2.89 units on a scale
Standard Deviation 1.69
|
|
Change in Visual Analogue Pain Score
36 hour with movement
|
5.29 units on a scale
Standard Deviation 1.60
|
7.00 units on a scale
Standard Deviation 1.79
|
6.83 units on a scale
Standard Deviation 2.23
|
6.33 units on a scale
Standard Deviation 1.94
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 36 hours after surgeryPopulation: Participants who completed pain score at specified time-points.
mg of morphine equivalents
Outcome measures
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=8 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=9 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=11 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Change in Opioid Consumption
6 hours
|
21.10 mg of morphine equivalents
Standard Deviation 15.94
|
22.20 mg of morphine equivalents
Standard Deviation 23.54
|
11.77 mg of morphine equivalents
Standard Deviation 11.75
|
33.50 mg of morphine equivalents
Standard Deviation 21.84
|
|
Change in Opioid Consumption
12 hours
|
42.24 mg of morphine equivalents
Standard Deviation 50.16
|
27.24 mg of morphine equivalents
Standard Deviation 30.03
|
54.23 mg of morphine equivalents
Standard Deviation 35.80
|
32.25 mg of morphine equivalents
Standard Deviation 30.74
|
|
Change in Opioid Consumption
18 hours
|
20.30 mg of morphine equivalents
Standard Deviation 16.77
|
16.86 mg of morphine equivalents
Standard Deviation 16.93
|
43.16 mg of morphine equivalents
Standard Deviation 55.34
|
29.75 mg of morphine equivalents
Standard Deviation 37.12
|
|
Change in Opioid Consumption
24 hours
|
25.50 mg of morphine equivalents
Standard Deviation 15.69
|
20.91 mg of morphine equivalents
Standard Deviation 17.93
|
25.86 mg of morphine equivalents
Standard Deviation 14.80
|
23.79 mg of morphine equivalents
Standard Deviation 21.79
|
|
Change in Opioid Consumption
36 hours
|
27.00 mg of morphine equivalents
Standard Deviation 25.22
|
24.61 mg of morphine equivalents
Standard Deviation 17.13
|
36.43 mg of morphine equivalents
Standard Deviation 26.25
|
21.29 mg of morphine equivalents
Standard Deviation 13.59
|
SECONDARY outcome
Timeframe: 30 days, 3 and 6 months following surgeryPopulation: Participants who completed questionnaire
The Western Ontario and McMaster Universities Osteoarthritis Index measures 17 items for functional limitation (score range 0-68). Higher score = higher difficulty with the task.
Outcome measures
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=9 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=11 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index
30 Days
|
25 units on a scale
Interval 18.5 to 34.0
|
29.5 units on a scale
Interval 21.25 to 38.75
|
42 units on a scale
Interval 33.0 to 43.0
|
30 units on a scale
Interval 23.5 to 44.5
|
|
Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index
3 months
|
17 units on a scale
Interval 12.0 to 23.5
|
32 units on a scale
Interval 24.5 to 40.25
|
19 units on a scale
Interval 12.0 to 35.0
|
24 units on a scale
Interval 12.25 to 33.75
|
|
Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index
6 months
|
14 units on a scale
Interval 7.5 to 22.5
|
24.5 units on a scale
Interval 12.75 to 29.5
|
17 units on a scale
Interval 11.5 to 22.0
|
16 units on a scale
Interval 9.0 to 23.0
|
SECONDARY outcome
Timeframe: Baseline at enrollment, 3 months and 6 months after surgeryPopulation: Participants who completed questionnaire
Brief pain inventory questionnaire will be administered generating a score (0-40). Higher scores reflect higher perceived pain.
Outcome measures
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=9 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=10 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire
Baseline
|
5 units on a scale
Interval 4.0 to 8.0
|
5 units on a scale
Interval 3.0 to 8.0
|
5 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 1.75 to 6.0
|
|
Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire
3 months
|
1 units on a scale
Interval 0.0 to 4.0
|
0.5 units on a scale
Interval 0.0 to 2.0
|
2 units on a scale
Interval 0.75 to 3.0
|
2 units on a scale
Interval 1.0 to 4.0
|
|
Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire
6 months
|
0 units on a scale
Interval 0.0 to 0.0
|
2.5 units on a scale
Interval 0.0 to 3.5
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.25
|
SECONDARY outcome
Timeframe: Baseline at Enrollment, 3 and 6 months after surgeryPopulation: Participants who completed questionnaire
Brief pain inventory questionnaire will be administered generating a score (0-70). Higher scores reflect higher perceived pain interference.
Outcome measures
| Measure |
Dexamethasone 6mg
n=11 Participants
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 Participants
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=9 Participants
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=10 Participants
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Change in Functional Status as Measured by Brief Pain Inventory Questionnaire
Baseline
|
5 units on a scale
Interval 4.0 to 8.0
|
5 units on a scale
Interval 3.0 to 8.0
|
5 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 1.75 to 6.0
|
|
Change in Functional Status as Measured by Brief Pain Inventory Questionnaire
3 Months
|
0 units on a scale
Interval 0.0 to 2.0
|
5 units on a scale
Interval 2.25 to 8.0
|
0 units on a scale
Interval 0.0 to 3.0
|
1.5 units on a scale
Interval 0.0 to 3.0
|
|
Change in Functional Status as Measured by Brief Pain Inventory Questionnaire
6 Months
|
0 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 4.75
|
0 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Samples will be taken immediately pre incision and will be repeated at 33-39hoursMacrophage totals and differentiation will be assessed within patients and between groups.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Sample immediately prior to incision and at 10-14, 22-26 and 33-39hours after surgery.Interleukin levels and the ratio will assess pro and anti inflammatory processes in the patients
Outcome measures
Outcome data not reported
Adverse Events
Dexamethasone 6mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dexamethasone 12mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dexamethasone 24mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone 6mg
n=11 participants at risk
Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 12mg
n=10 participants at risk
Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Dexamethasone 24mg
n=10 participants at risk
Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
|
Placebo
n=11 participants at risk
Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.
Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
|
|---|---|---|---|---|
|
Renal and urinary disorders
urine retention
|
0.00%
0/11 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
10.0%
1/10 • Number of events 1 • Randomization to 6 month follow up
|
9.1%
1/11 • Number of events 1 • Randomization to 6 month follow up
|
|
Musculoskeletal and connective tissue disorders
fall
|
0.00%
0/11 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
10.0%
1/10 • Number of events 1 • Randomization to 6 month follow up
|
9.1%
1/11 • Number of events 1 • Randomization to 6 month follow up
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/11 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
20.0%
2/10 • Number of events 2 • Randomization to 6 month follow up
|
18.2%
2/11 • Number of events 2 • Randomization to 6 month follow up
|
|
General disorders
dizziness
|
0.00%
0/11 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
10.0%
1/10 • Number of events 2 • Randomization to 6 month follow up
|
0.00%
0/11 • Randomization to 6 month follow up
|
|
Cardiac disorders
hypotension
|
9.1%
1/11 • Number of events 1 • Randomization to 6 month follow up
|
10.0%
1/10 • Number of events 1 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
18.2%
2/11 • Number of events 2 • Randomization to 6 month follow up
|
|
Injury, poisoning and procedural complications
wound dehisence
|
0.00%
0/11 • Randomization to 6 month follow up
|
10.0%
1/10 • Number of events 1 • Randomization to 6 month follow up
|
0.00%
0/10 • Randomization to 6 month follow up
|
0.00%
0/11 • Randomization to 6 month follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place