Trial Outcomes & Findings for Postoperative Pain Management in Rhinoplasty (NCT NCT03584152)
NCT ID: NCT03584152
Last Updated: 2025-12-03
Results Overview
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
COMPLETED
PHASE2
159 participants
5 days post-operative [up to approximately 5 weeks post-baseline]
2025-12-03
Participant Flow
Participants were enrolled from the day of the pre-operative appointment (approximately 2 to 4 weeks prior to procedure) through post-operative day 7. Follow-up data at two time points (\<6 months, and ≥ 6 months) were obtained by chart review.
159 signed informed consent and 141 participants were randomized.
Participant milestones
| Measure |
Drug Arm A
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
Drug Arm B
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
69
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Drug Arm A
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
Drug Arm B
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Overall Study
Discontinued intervention
|
7
|
4
|
Baseline Characteristics
Postoperative Pain Management in Rhinoplasty
Baseline characteristics by cohort
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Total
n=130 Participants
Total of all reporting groups
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 12.4 • n=6 Participants
|
32.1 years
STANDARD_DEVIATION 10.7 • n=9 Participants
|
30.7 years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=6 Participants
|
100 Participants
n=9 Participants
|
48 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
17 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=6 Participants
|
89 Participants
n=9 Participants
|
44 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
15 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Latino/ Hispanic
|
10 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=6 Participants
|
130 Participants
n=9 Participants
|
65 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 5 days post-operative [up to approximately 5 weeks post-baseline]Population: Participants who completed the intervention.
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
|
41 score on a scale
Standard Deviation 16.3
|
44 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who completed the intervention.
Use of any study medication, excluding tramadol.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Number of Study Drugs (Doses) Utilized
|
19 doses
Standard Deviation 9.9
|
16 doses
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who completed the intervention.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Number of Tramadol Doses Utilized
|
2.0 doses
Standard Deviation 3.7
|
1 doses
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who completed the intervention.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Number Patients Who Reported Adequate Pain Control
No (not adequate)
|
2 Participants
|
4 Participants
|
|
Number Patients Who Reported Adequate Pain Control
Yes (adequate)
|
63 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Participants who completed the intervention.
Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Side Effects of Pain Medications
Constipation
|
19 Participants
|
22 Participants
|
|
Side Effects of Pain Medications
Dizziness
|
31 Participants
|
41 Participants
|
|
Side Effects of Pain Medications
Bleeding
|
28 Participants
|
30 Participants
|
|
Side Effects of Pain Medications
Headache
|
8 Participants
|
9 Participants
|
|
Side Effects of Pain Medications
Other
|
3 Participants
|
7 Participants
|
|
Side Effects of Pain Medications
Itchiness
|
2 Participants
|
14 Participants
|
|
Side Effects of Pain Medications
Nausea
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline and post-operative follow-up (up to an average of 12 months following procedure)Population: Participants who completed the intervention.
The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
SCHNOS-O (pre-operative)
|
41.0 score on a scale
Standard Deviation 36.1
|
40.0 score on a scale
Standard Deviation 33.2
|
|
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
Change in SCHNOS-O (post-operative)
|
-23.4 score on a scale
Standard Deviation 41.9
|
-25.7 score on a scale
Standard Deviation 35.0
|
|
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
SCHNOS-C (pre-operative)
|
54.0 score on a scale
Standard Deviation 26.4
|
54.0 score on a scale
Standard Deviation 29.0
|
|
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
Change in SCHNOS-C (post-operative)
|
-36.0 score on a scale
Standard Deviation 34.2
|
-39.6 score on a scale
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: Baseline and post-operative follow-up (up to an average of 12 months following procedure)Population: Participants who completed the intervention.
Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Visual Analog Scale-Functional (VAS-F)
Pre-operative
|
4.0 score on a scale
Standard Deviation 3.1
|
4.0 score on a scale
Standard Deviation 3.1
|
|
Visual Analog Scale-Functional (VAS-F)
Post-operative (change)
|
-1.8 score on a scale
Standard Deviation 3.5
|
-1.8 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and post-operative follow-up (up to an average of 12 months following procedure)Population: Participants who completed the intervention.
Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Visual Analog Scale-Aesthetic (VAS-A)
Pre-operative
|
3.0 score on a scale
Standard Deviation 2.5
|
3.0 score on a scale
Standard Deviation 2.3
|
|
Visual Analog Scale-Aesthetic (VAS-A)
Post-operative (change)
|
-1.2 score on a scale
Standard Deviation 3.1
|
-1.5 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Post-operative day 7Population: Participants who completed the intervention.
Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Eyelid Edema Score
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Post-operative day 7Population: Participants who completed the intervention.
Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Ecchymosis Score
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Post-operative day 7Population: Participants who completed the intervention.
Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage.
Outcome measures
| Measure |
Drug Arm B
n=65 Participants
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
|
Drug Arm A
n=65 Participants
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.
|
|---|---|---|
|
Subconjunctival Hemorrhage Score
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 1.0
|
Adverse Events
Drug Arm A
Drug Arm B
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