Trial Outcomes & Findings for Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty (NCT NCT03457116)

Results Overview

Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

Day 0

Results posted on

2021-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	NSAIDS 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Overall Study STARTED	41	29
Overall Study COMPLETED	41	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates n=29 Participants Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)	Total n=70 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	32 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	39 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	41 Participants n=5 Participants	29 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

Outcome measures

Outcome measures
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates n=29 Participants Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Average Pain Score	2.54 score on a scale Standard Deviation 1.57	3.14 score on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: Day 1

Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

Outcome measures

Outcome measures
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates n=29 Participants Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Average Pain Score	1.84 score on a scale Standard Deviation 1.29	2.46 score on a scale Standard Deviation 1.90

PRIMARY outcome

Timeframe: Day 7

Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

Outcome measures

Outcome measures
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates n=29 Participants Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Average Pain Score	3.29 score on a scale Standard Deviation 2.14	3.14 score on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: Day 7

Self-reported via Post-Operative Pain Management Survey

Outcome measures

Outcome measures
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates n=29 Participants Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Average Post-Operative Day (POD) of Medication Cessation	4.73 days Standard Deviation 1.57	4.28 days Standard Deviation 2.23

SECONDARY outcome

Timeframe: Day 7

Population: This outcome measure is only applicable to NSAIDS

Outcome measures

Outcome measures
Measure	NSAIDS n=41 Participants 400mg of Ibuprofen NSAID: Ibuprofen 400mg for post-operative pain	Opiates Norco (hydrocodone 5mg- acetaminophen 325mg) Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain	5 Participants	—

Adverse Events

NSAIDS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opiates

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

Judy Lee, MD

NYU Langone Health

Phone: (646) 501-7906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place