Trial Outcomes & Findings for Postoperative Pain Control in Septum and Sinus Surgery (NCT NCT04149964)
NCT ID: NCT04149964
Last Updated: 2023-08-31
Results Overview
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
COMPLETED
PHASE4
65 participants
7 days
2023-08-31
Participant Flow
Participant milestones
| Measure |
Standard of Care Arm
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
Reasons for withdrawal
| Measure |
Standard of Care Arm
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
18
|
Baseline Characteristics
65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Baseline characteristics by cohort
| Measure |
Standard of Care Arm
n=34 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=31 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.73 years
STANDARD_DEVIATION 15.40 • n=34 Participants
|
46 years
STANDARD_DEVIATION 14.26 • n=31 Participants
|
44.34 years
STANDARD_DEVIATION 6.79 • n=65 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
4 Participants
n=13 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
14 Participants
n=28 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
9 Participants
n=13 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
14 Participants
n=28 Participants • 65 patients were enrolled. Baseline data on sex is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
31 participants
n=31 Participants
|
65 participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Number of Doses of Opiate (Narcotic) Pain Medication
|
1.0 number of doses
Interval 0.0 to 4.5
|
1.5 number of doses
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Highest Subjective Pain Score
|
6.0 score on a scale
Interval 4.25 to 7.0
|
5.0 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Lowest Subjective Pain Score
|
2.0 score on a scale
Interval 0.0 to 3.0
|
2.0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Percentage of Time Participant Experienced Severe Pain
|
0 percentage of time
Interval 0.0 to 45.0
|
0 percentage of time
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Number of participants who took acetaminophen as needed during the first postoperative week.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Participant Use of Acetaminophen as Needed
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Participant Use of Scheduled Acetaminophen Around the Clock
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Number of participants who answered "Yes" to the survey question, "Do you take pain medication, including narcotics, for any other medical condition?"
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Chronic Use of Pain Medication
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week.
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Participant Use of Additional Pain Medication
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week
Outcome measures
| Measure |
Standard of Care Arm
n=15 Participants
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
|
Study Arm
n=13 Participants
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain
|
|---|---|---|
|
Types of Other Pain Medication Used
Acetaminophen 325mg with 60mg codeine
|
1 Participants
|
0 Participants
|
|
Types of Other Pain Medication Used
morphine 15mg twice daily, 25mcg fentanyl
|
0 Participants
|
1 Participants
|
|
Types of Other Pain Medication Used
ibuprofen
|
1 Participants
|
0 Participants
|
|
Types of Other Pain Medication Used
None
|
13 Participants
|
12 Participants
|
Adverse Events
Standard of Care Arm
Study Arm
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