Trial Outcomes & Findings for Overnight Pain Treatment Investigating Opioids vs. Nonopioids (NCT NCT03545893)
NCT ID: NCT03545893
Last Updated: 2020-03-25
Results Overview
Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain")
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
24 hours
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
Ibuprofen
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
|
Ibuprofen + Oxycodone
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Baseline characteristics by cohort
| Measure |
Ibuprofen
n=35 Participants
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
|
Ibuprofen + Oxycodone
n=35 Participants
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
30.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain")
Outcome measures
| Measure |
Ibuprofen
n=35 Participants
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
|
Ibuprofen + Oxycodone
n=35 Participants
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
|
|---|---|---|
|
Maximum Pain Score
|
4.66 score on a scale
Standard Deviation 2.86
|
6.51 score on a scale
Standard Deviation 2.50
|
Adverse Events
Ibuprofen
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Ibuprofen + Oxycodone
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen
n=35 participants at risk
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
|
Ibuprofen + Oxycodone
n=35 participants at risk
Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
31.4%
11/35 • Number of events 11 • 2 days
|
51.4%
18/35 • Number of events 18 • 2 days
|
|
Reproductive system and breast disorders
Uterine Cramping
|
82.9%
29/35 • Number of events 29 • 2 days
|
82.9%
29/35 • Number of events 29 • 2 days
|
|
Reproductive system and breast disorders
Vaginal spotting
|
51.4%
18/35 • Number of events 18 • 2 days
|
62.9%
22/35 • Number of events 22 • 2 days
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
17.1%
6/35 • Number of events 6 • 2 days
|
34.3%
12/35 • Number of events 12 • 2 days
|
|
Reproductive system and breast disorders
Uterine pain
|
11.4%
4/35 • Number of events 4 • 2 days
|
17.1%
6/35 • Number of events 6 • 2 days
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Number of events 2 • 2 days
|
17.1%
6/35 • Number of events 6 • 2 days
|
|
Nervous system disorders
Drowsiness
|
5.7%
2/35 • Number of events 2 • 2 days
|
20.0%
7/35 • Number of events 7 • 2 days
|
|
Skin and subcutaneous tissue disorders
Itching
|
8.6%
3/35 • Number of events 3 • 2 days
|
5.7%
2/35 • Number of events 2 • 2 days
|
Additional Information
Arden McAllister, Research Program Manager
University of Pennsylvania
Phone: 215-662-3532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place