Trial Outcomes & Findings for Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia (NCT NCT05544734)
NCT ID: NCT05544734
Last Updated: 2023-09-28
Results Overview
Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline, 2 days
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Hydrocodone 5mg/Acetaminophen 325mg
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
Acetaminophen 1000mg + Ibuprofen 400mg
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Baseline characteristics by cohort
| Measure |
Hydrocodone 5mg/Acetaminophen 325mg
n=10 Participants
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
Acetaminophen 1000mg + Ibuprofen 400mg
n=10 Participants
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
53.3 years
n=5 Participants
|
47.7 years
n=7 Participants
|
50.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 daysChange in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.
Outcome measures
| Measure |
Hydrocodone 5mg/Acetaminophen 325mg
n=10 Participants
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
Acetaminophen 1000mg + Ibuprofen 400mg
n=10 Participants
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
|---|---|---|
|
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
|
2.1 score on a scale
Standard Deviation 1.6
|
2.4 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 3 days, 6 days (end of study)Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).
Outcome measures
| Measure |
Hydrocodone 5mg/Acetaminophen 325mg
n=10 Participants
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
Acetaminophen 1000mg + Ibuprofen 400mg
n=10 Participants
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg: 1000 mg tablet
Ibuprofen 400 mg: 400 mg tablet
|
|---|---|---|
|
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire
|
12.7 score on a scale
Standard Deviation 11.2
|
10.4 score on a scale
Standard Deviation 9.0
|
Adverse Events
Hydrocodone 5mg/Acetaminophen 325mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen 1000mg + Ibuprofen 400mg
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