Trial Outcomes & Findings for Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis (NCT NCT03055507)
NCT ID: NCT03055507
Last Updated: 2023-03-22
Results Overview
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
42 participants
Primary outcome timeframe
Post-operative day 1
Results posted on
2023-03-22
Participant Flow
Participant milestones
| Measure |
Control
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
26
|
|
Overall Study
COMPLETED
|
16
|
26
|
|
Overall Study
NOT COMPLETED
|
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 |
Control
n=16 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=26 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 16 • n=16 Participants
|
53 years
STANDARD_DEVIATION 18.5 • n=26 Participants
|
49 years
STANDARD_DEVIATION 17 • n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=16 Participants
|
14 Participants
n=26 Participants
|
22 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=16 Participants
|
12 Participants
n=26 Participants
|
20 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
26 participants
n=26 Participants
|
42 participants
n=42 Participants
|
|
Chronic rhinonsinusitis (CRS) with Nasal Polyposis
|
1 Participants
n=16 Participants
|
12 Participants
n=26 Participants
|
13 Participants
n=42 Participants
|
|
Duration of surgery
|
90 minutes
STANDARD_DEVIATION 44.2 • n=16 Participants
|
91 minutes
STANDARD_DEVIATION 49.1 • n=26 Participants
|
90 minutes
STANDARD_DEVIATION 46 • n=42 Participants
|
|
Estimated blood loss
|
49 milliliters
STANDARD_DEVIATION 34.7 • n=16 Participants
|
51 milliliters
STANDARD_DEVIATION 22.6 • n=26 Participants
|
51 milliliters
STANDARD_DEVIATION 30 • n=42 Participants
|
|
Lund-MacKay CT grading Score
|
9.4 units on a scale
STANDARD_DEVIATION 6 • n=16 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 6 • n=26 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 6 • n=42 Participants
|
|
Sinonasal outcome test-22 score (SNOT-22)
|
44 units on a scale
STANDARD_DEVIATION 22.6 • n=16 Participants
|
42 units on a scale
STANDARD_DEVIATION 18.9 • n=26 Participants
|
42 units on a scale
STANDARD_DEVIATION 19.7 • n=42 Participants
|
|
Number of sinuses operated
|
5.3 sinuses
STANDARD_DEVIATION 2.4 • n=16 Participants
|
5.9 sinuses
STANDARD_DEVIATION 1.8 • n=26 Participants
|
5.7 sinuses
STANDARD_DEVIATION 2.1 • n=42 Participants
|
PRIMARY outcome
Timeframe: Post-operative day 110-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Outcome measures
| Measure |
Control
n=16 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=26 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Pain Visual Analogue Scale (VAS)
|
3.3 units on a scale
Standard Deviation 2.1
|
2.3 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Post-operative day 3Population: Patients undergoing sinus surgery stratified into study arms
10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Outcome measures
| Measure |
Control
n=16 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=26 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Pain Visual Analogue Scale
|
3.0 units on a scale
Standard Deviation 2.1
|
1.7 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Post-operative day 7Population: Same as previous
10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
Outcome measures
| Measure |
Control
n=16 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=26 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Pain Visual Analogue Scale
|
3.3 units on the pain visual analogue scale
Standard Deviation 2.1
|
2.3 units on the pain visual analogue scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Post-operative days 1-7Number of opioid pills taken daily following surgery
Outcome measures
| Measure |
Control
n=16 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=24 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Number of Opioid Pills
|
4 pills per day
Standard Deviation 1
|
4 pills per day
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Post-operative days 1, 3, and 710-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding
Outcome measures
| Measure |
Control
n=15 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=24 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
Bleeding Visual Analogue Scale
Post-operative day 1
|
3.2 units on a scale
Standard Deviation 2.0
|
2.3 units on a scale
Standard Deviation 2.1
|
|
Bleeding Visual Analogue Scale
Post-operative day 3
|
3.2 units on a scale
Standard Deviation 2.1
|
2.3 units on a scale
Standard Deviation 1.8
|
|
Bleeding Visual Analogue Scale
Post-operative day 7
|
1.2 units on a scale
Standard Deviation 0.6
|
0.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Post-operative days 1, 3, and 7Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding.
Outcome measures
| Measure |
Control
n=15 Participants
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN pain.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
Ibuprofen
n=24 Participants
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Ibuprofen 400 mg: Addition of ibuprofen to standard pain regimen.
Acetaminophen 650 mg: Standard analgesic provided post-operatively to patients undergoing sinus surgery
OxyCODONE 5 Mg Oral Tablet: Standard PRN medication offered post-operatively for breakthrough pain
|
|---|---|---|
|
0-4 Bleeding Scale
Post-operative day 1
|
1.5 score on a scale
Standard Deviation 1.0
|
0.9 score on a scale
Standard Deviation 0.6
|
|
0-4 Bleeding Scale
Post-operative day 3
|
1.5 score on a scale
Standard Deviation 1.0
|
0.9 score on a scale
Standard Deviation 0.6
|
|
0-4 Bleeding Scale
Post-operative day 7
|
0.7 score on a scale
Standard Deviation 0.6
|
0.3 score on a scale
Standard Deviation 0.5
|
POST_HOC outcome
Timeframe: Post operative days 1, 3 & 7Population: No participants were analyzed
Number of changes to post-operative wound dressing. This outcome was not collected based on difficulty with patient compliance. No data was gathered on this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen
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
Dr. Greg Davis, Director of Rhinology and Skull Base
University of Washington, Department of Otolaryngology - Head & Neck Surgery
Phone: (206) 598-4022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place