Trial Outcomes & Findings for Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries (NCT NCT02313675)
NCT ID: NCT02313675
Last Updated: 2018-05-04
Results Overview
This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
7 days
Results posted on
2018-05-04
Participant Flow
Participant milestones
| Measure |
IV Tylenol
One time intra-operative IV acetaminophen administration
Acetaminophen
|
IV Toradol
One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine
|
IV Tylenol/Toradol Combination
One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine
|
Saline
One time intra-operative 50ml IV normal saline administration
Saline
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IV Tylenol
n=11 Participants
One time intra-operative IV acetaminophen administration
Acetaminophen
|
IV Toradol
n=11 Participants
One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine
|
IV Tylenol/Toradol Combination
n=11 Participants
One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine
|
Saline
n=11 Participants
One time intra-operative 50ml IV normal saline administration
Saline
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=11 Participants
|
48 years
n=11 Participants
|
43 years
n=11 Participants
|
55 years
n=11 Participants
|
51 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=11 Participants
|
8 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
6 Participants
n=11 Participants
|
28 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
16 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 7 daysThis is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.
Outcome measures
| Measure |
IV Tylenol
n=11 Participants
One time intra-operative IV acetaminophen administration
Acetaminophen
|
IV Toradol
n=11 Participants
One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine
|
IV Tylenol/Toradol Combination
n=11 Participants
One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine
|
Saline
n=11 Participants
One time intra-operative 50ml IV normal saline administration
Saline
|
|---|---|---|---|---|
|
Postoperative Pain (Pain Scores From 0-10 Scale)
|
2.0 units on a scale
Interval 1.7 to 2.3
|
2.9 units on a scale
Interval 2.6 to 3.2
|
2.7 units on a scale
Interval 2.3 to 3.0
|
2.0 units on a scale
Interval 1.7 to 2.3
|
SECONDARY outcome
Timeframe: 7 daysDaily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively Outcome measure reported below is mean number of opioid pills consumed per day.
Outcome measures
| Measure |
IV Tylenol
n=11 Participants
One time intra-operative IV acetaminophen administration
Acetaminophen
|
IV Toradol
n=11 Participants
One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine
|
IV Tylenol/Toradol Combination
n=11 Participants
One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine
|
Saline
n=11 Participants
One time intra-operative 50ml IV normal saline administration
Saline
|
|---|---|---|---|---|
|
Opioid Consumption (Number of Pills Taken)
|
0.2 pills consumed
Interval 0.0 to 12.0
|
0.7 pills consumed
Interval 0.0 to 16.0
|
1.0 pills consumed
Interval 0.0 to 20.0
|
0.7 pills consumed
Interval 0.0 to 16.0
|
Adverse Events
IV Tylenol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Toradol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Tylenol/Toradol Combination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place