Trial Outcomes & Findings for Pain Control Following Sinus Surgery (NCT NCT03783702)
NCT ID: NCT03783702
Last Updated: 2021-09-01
Results Overview
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
COMPLETED
PHASE4
118 participants
Average pain score will be collected for preoperative visit (the day before surgery)
2021-09-01
Participant Flow
Participant milestones
| Measure |
Experimental Group
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
62
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Experimental Group
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
Protocol Violation
|
1
|
3
|
Baseline Characteristics
Pain Control Following Sinus Surgery
Baseline characteristics by cohort
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
83 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Prior sinus surgery
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Lund-mackay score
|
9.7 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 5.9 • n=7 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Total baseline SNOT-22 score
|
39.6 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 19.8 • n=7 Participants
|
40.5 units on a scale
STANDARD_DEVIATION 19.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Average pain score will be collected for preoperative visit (the day before surgery)A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
12.4 units on a scale
Standard Deviation 20.0
|
8.5 units on a scale
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: Average pain score was collected for postoperative day 1A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
30.2 units on a scale
Standard Deviation 26.6
|
29.4 units on a scale
Standard Deviation 26.0
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 2A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
27.0 units on a scale
Standard Deviation 24.8
|
23.5 units on a scale
Standard Deviation 23.2
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 3A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
19.2 units on a scale
Standard Deviation 22.6
|
22.5 units on a scale
Standard Deviation 19.0
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 4A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
14.1 units on a scale
Standard Deviation 18.7
|
16.8 units on a scale
Standard Deviation 18.1
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 5A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
15.8 units on a scale
Standard Deviation 21.8
|
15.0 units on a scale
Standard Deviation 19.6
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 6A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
13.9 units on a scale
Standard Deviation 19.0
|
11.7 units on a scale
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: Average pain score will be collected for postoperative day 7A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Pain Severity
|
8.1 units on a scale
Standard Deviation 9.8
|
10.1 units on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: Postoperative day 1 to 7Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Medication Log
Oxycodone POD1
|
0.3 Average number of medication doses/day
Standard Deviation 0.7
|
0.6 Average number of medication doses/day
Standard Deviation 1.1
|
|
Medication Log
Oxycodone POD2
|
0.1 Average number of medication doses/day
Standard Deviation 0.3
|
0.4 Average number of medication doses/day
Standard Deviation 1.0
|
|
Medication Log
Oxycodone POD3
|
0.1 Average number of medication doses/day
Standard Deviation 0.2
|
0.3 Average number of medication doses/day
Standard Deviation 0.8
|
|
Medication Log
Oxycodone POD4
|
0.1 Average number of medication doses/day
Standard Deviation 0.3
|
0.3 Average number of medication doses/day
Standard Deviation 0.7
|
|
Medication Log
Oxycodone POD5
|
0.1 Average number of medication doses/day
Standard Deviation 0.4
|
0.3 Average number of medication doses/day
Standard Deviation 1.1
|
|
Medication Log
Oxycodone POD6
|
0.1 Average number of medication doses/day
Standard Deviation 0.3
|
0.1 Average number of medication doses/day
Standard Deviation 0.6
|
|
Medication Log
Oxycodone POD7
|
0 Average number of medication doses/day
Standard Deviation 0.2
|
0 Average number of medication doses/day
Standard Deviation 0.2
|
|
Medication Log
Acetaminophen POD1
|
2.0 Average number of medication doses/day
Standard Deviation 1.5
|
2.1 Average number of medication doses/day
Standard Deviation 1.8
|
|
Medication Log
Acetaminophen POD2
|
1.8 Average number of medication doses/day
Standard Deviation 1.4
|
1.9 Average number of medication doses/day
Standard Deviation 1.9
|
|
Medication Log
Acetaminophen POD3
|
1.3 Average number of medication doses/day
Standard Deviation 1.3
|
1.6 Average number of medication doses/day
Standard Deviation 1.6
|
|
Medication Log
Acetaminophen POD4
|
1.0 Average number of medication doses/day
Standard Deviation 1.5
|
1.5 Average number of medication doses/day
Standard Deviation 1.4
|
|
Medication Log
Acetaminophen POD5
|
0.9 Average number of medication doses/day
Standard Deviation 1.2
|
1.3 Average number of medication doses/day
Standard Deviation 1.4
|
|
Medication Log
Acetaminophen POD6
|
0.9 Average number of medication doses/day
Standard Deviation 1.3
|
1.1 Average number of medication doses/day
Standard Deviation 1.3
|
|
Medication Log
Acetaminophen POD7
|
0.6 Average number of medication doses/day
Standard Deviation 1.0
|
0.6 Average number of medication doses/day
Standard Deviation 0.8
|
|
Medication Log
Ibuprofen POD1
|
0.6 Average number of medication doses/day
Standard Deviation 0.9
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD2
|
0.5 Average number of medication doses/day
Standard Deviation 0.8
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD3
|
0.4 Average number of medication doses/day
Standard Deviation 0.9
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD4
|
0.3 Average number of medication doses/day
Standard Deviation 0.8
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD5
|
0.4 Average number of medication doses/day
Standard Deviation 0.8
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD6
|
0.3 Average number of medication doses/day
Standard Deviation 0.6
|
0 Average number of medication doses/day
Standard Deviation 0
|
|
Medication Log
Ibuprofen POD7
|
0.2 Average number of medication doses/day
Standard Deviation 0.5
|
0 Average number of medication doses/day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: BPI score will be collected at the preoperative visitThe Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.6 units on a scale
Standard Deviation 2.2
|
1.0 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 1The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
2.8 units on a scale
Standard Deviation 2.3
|
2.9 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 2The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
2.5 units on a scale
Standard Deviation 2.1
|
2.3 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 3The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.9 units on a scale
Standard Deviation 2.0
|
2.1 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 4The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.5 units on a scale
Standard Deviation 1.8
|
1.9 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 5The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.7 units on a scale
Standard Deviation 2.1
|
1.6 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 6The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.5 units on a scale
Standard Deviation 1.9
|
1.4 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Average BPI score will be collected for postoperative day 7The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Brief Pain Inventory (BPI) Score
|
1.3 units on a scale
Standard Deviation 1.7
|
1.4 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected at the preoperative visitA 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 1A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
36.3 units on a scale
Standard Deviation 33.2
|
38.9 units on a scale
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 2A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
23.0 units on a scale
Standard Deviation 27.1
|
21.6 units on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 3A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
15.9 units on a scale
Standard Deviation 22.0
|
12.9 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 4A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
9.3 units on a scale
Standard Deviation 15.2
|
11.8 units on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 5A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
10.1 units on a scale
Standard Deviation 20.1
|
7.8 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 6A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
6.5 units on a scale
Standard Deviation 11.6
|
6.6 units on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Epistaxis severity will be collected for postoperative day 7A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.
Outcome measures
| Measure |
Experimental Group
n=49 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
Control Group
n=51 Participants
1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
|
|---|---|---|
|
Severity of Epistaxis
|
4.6 units on a scale
Standard Deviation 9.2
|
5.4 units on a scale
Standard Deviation 12.5
|
Adverse Events
Experimental Group
Control Group
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