Trial Outcomes & Findings for Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty (NCT NCT03605914)
NCT ID: NCT03605914
Last Updated: 2021-07-20
Results Overview
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
24 hours (day 1 after operation)
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
NSAID
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
43
|
|
Overall Study
Completed Day 1 Assessment
|
31
|
26
|
|
Overall Study
Completed Day 2 Assessment
|
32
|
27
|
|
Overall Study
Completed Day 3 Assessment
|
31
|
28
|
|
Overall Study
Completed Day 5 Assessment
|
30
|
24
|
|
Overall Study
COMPLETED
|
30
|
24
|
|
Overall Study
NOT COMPLETED
|
27
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NSAID
n=57 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=43 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 15.7 • n=57 Participants
|
46.2 years
STANDARD_DEVIATION 15.3 • n=43 Participants
|
45.7 years
STANDARD_DEVIATION 15.5 • n=100 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=57 Participants
|
17 Participants
n=43 Participants
|
37 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=57 Participants
|
26 Participants
n=43 Participants
|
63 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
57 Participants
n=57 Participants
|
43 Participants
n=43 Participants
|
100 Participants
n=100 Participants
|
|
Number of participants with history of anxiety
|
6 Participants
n=57 Participants
|
3 Participants
n=43 Participants
|
9 Participants
n=100 Participants
|
|
Number of participants with history of depression
|
4 Participants
n=57 Participants
|
3 Participants
n=43 Participants
|
7 Participants
n=100 Participants
|
|
Number of participants with history of migraine
|
5 Participants
n=57 Participants
|
3 Participants
n=43 Participants
|
8 Participants
n=100 Participants
|
|
Number of participants with history of temporomandibular joint (TMJ) dysfunction
|
0 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=100 Participants
|
|
Number of participants with history of fibromyalgia
|
0 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=100 Participants
|
|
Number of participants with history of pain disorder
|
0 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=100 Participants
|
|
Number of participants currently on pain medication
|
1 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=100 Participants
|
|
Number of participants currently on opioid
|
0 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=100 Participants
|
|
Number of participants currently on NSAID
|
1 Participants
n=57 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 24 hours (day 1 after operation)Population: Data was not collected for 26 in the NSAID arm and 17 in the opioid arm.
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Outcome measures
| Measure |
NSAID
n=31 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=26 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
|
30.2 units on a scale
Standard Deviation 25.3
|
40.7 units on a scale
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: 48 hours (day 2 after operation)Population: Data was not collected for 25 in the NSAID arm and 16 in the opioid arm.
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Outcome measures
| Measure |
NSAID
n=32 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=27 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
|
24.2 units on a scale
Standard Deviation 25.1
|
28.3 units on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 72 hours (day 3 after operation)Population: Data was not collected for 26 in the NSAID arm and 15 in the opioid arm.
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Outcome measures
| Measure |
NSAID
n=31 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=28 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
|
22.9 units on a scale
Standard Deviation 20.4
|
27.9 units on a scale
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: 120 hours (day 5 after operation)Population: Data was not collected for 27 in the NSAID arm and 19 in the opioid arm.
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Outcome measures
| Measure |
NSAID
n=30 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=24 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
|
17.2 units on a scale
Standard Deviation 20.3
|
18.9 units on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 5 days after operationPopulation: Data was not collected for 27 in the NSAID arm and 19 in the opioid arm.
Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.
Outcome measures
| Measure |
NSAID
n=30 Participants
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
|
Opioid
n=24 Participants
The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
|
|---|---|---|
|
Number of Participants With Bleeding Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 days after operationPopulation: No data were collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 days after operationPopulation: No data were collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
NSAID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid
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
Martin J. Citardi, MD, Professor and Chair, Department of Otorhinolaryngology
The University of Texas Health Science Center at Houston
Phone: (713) 500-5410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place