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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: 5 days post-operative [up to approximately 5 weeks post-baseline]
• Results posted on: 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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
Age, Continuous	30.7 years STANDARD_DEVIATION 8.6 • n=3 Participants	33.5 years STANDARD_DEVIATION 12.4 • n=3 Participants	32.1 years STANDARD_DEVIATION 10.7 • n=6 Participants
Sex: Female, Male Female	48 Participants n=3 Participants	52 Participants n=3 Participants	100 Participants n=6 Participants
Sex: Female, Male Male	17 Participants n=3 Participants	13 Participants n=3 Participants	30 Participants n=6 Participants
Race/Ethnicity, Customized White	44 Participants n=3 Participants	45 Participants n=3 Participants	89 Participants n=6 Participants
Race/Ethnicity, Customized Asian	15 Participants n=3 Participants	10 Participants n=3 Participants	25 Participants n=6 Participants
Race/Ethnicity, Customized Latino/ Hispanic	6 Participants n=3 Participants	10 Participants n=3 Participants	16 Participants n=6 Participants
Region of Enrollment United States	65 Participants n=3 Participants	65 Participants n=3 Participants	130 Participants n=6 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)	44 score on a scale Standard Deviation 14.1	41 score on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: 5 days

Population: Participants who completed the intervention.

Use of any study medication, excluding tramadol.

Outcome measures

Measure	Drug Arm A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Number of Study Drugs (Doses) Utilized	16 doses Standard Deviation 9.5	19 doses Standard Deviation 9.9

SECONDARY outcome

Timeframe: 5 days

Population: Participants who completed the intervention.

Outcome measures

Measure	Drug Arm A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Number of Tramadol Doses Utilized	1 doses Standard Deviation 2.5	2.0 doses Standard Deviation 3.7

SECONDARY outcome

Timeframe: 5 days

Population: Participants who completed the intervention.

Outcome measures

Measure	Drug Arm A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Number Patients Who Reported Adequate Pain Control Yes (adequate)	61 Participants	63 Participants
Number Patients Who Reported Adequate Pain Control No (not adequate)	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 5 days

Population: 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Side Effects of Pain Medications Headache	9 Participants	8 Participants
Side Effects of Pain Medications Nausea	17 Participants	13 Participants
Side Effects of Pain Medications Itchiness	14 Participants	2 Participants
Side Effects of Pain Medications Constipation	22 Participants	19 Participants
Side Effects of Pain Medications Dizziness	41 Participants	31 Participants
Side Effects of Pain Medications Bleeding	30 Participants	28 Participants
Side Effects of Pain Medications Other	7 Participants	3 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire SCHNOS-O (pre-operative)	40.0 score on a scale Standard Deviation 33.2	41.0 score on a scale Standard Deviation 36.1
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire Change in SCHNOS-O (post-operative)	-25.7 score on a scale Standard Deviation 35.0	-23.4 score on a scale Standard Deviation 41.9
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire SCHNOS-C (pre-operative)	54.0 score on a scale Standard Deviation 29.0	54.0 score on a scale Standard Deviation 26.4
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire Change in SCHNOS-C (post-operative)	-39.6 score on a scale Standard Deviation 30.7	-36.0 score on a scale Standard Deviation 34.2

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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
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 3.0	-1.8 score on a scale Standard Deviation 3.5

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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Visual Analog Scale-Aesthetic (VAS-A) Pre-operative	3.0 score on a scale Standard Deviation 2.3	3.0 score on a scale Standard Deviation 2.5
Visual Analog Scale-Aesthetic (VAS-A) Post-operative (change)	-1.5 score on a scale Standard Deviation 2.7	-1.2 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Post-operative day 7

Population: 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
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 7

Population: 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
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 7

Population: 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 A n=65 Participants Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total.	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.
Subconjunctival Hemorrhage Score	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval 0.0 to 2.0

Adverse Events

Drug Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug Arm B

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

Sam P. Most, MD, MBA

Stanford University

Phone: (650) 724-8019

Email: smost@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place