Trial Outcomes & Findings for Patient Narcotic Requirements After Outpatient Otolaryngology Procedures (NCT NCT03404518)

NCT ID: NCT03404518

Last Updated: 2022-03-16

Results Overview

The average number of narcotic pills needed or used for pain control

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 185 participants
• Primary outcome timeframe: First 7 days after surgery
• Results posted on: 2022-03-16

Participant Flow

Participant milestones

Measure	Norco and Ibuprofen This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Overall Study STARTED	97	88
Overall Study COMPLETED	56	52
Overall Study NOT COMPLETED	41	36

Reasons for withdrawal

Measure	Norco and Ibuprofen This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Overall Study Lost to Follow-up	28	30
Overall Study Protocol Violation	13	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Norco and Ibuprofen n=56 Participants This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco n=52 Participants This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control	Total n=108 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 17 • n=56 Participants	52.9 years STANDARD_DEVIATION 17 • n=52 Participants	53 years STANDARD_DEVIATION 17 • n=108 Participants
Sex: Female, Male Female	37 Participants n=56 Participants	26 Participants n=52 Participants	63 Participants n=108 Participants
Sex: Female, Male Male	19 Participants n=56 Participants	26 Participants n=52 Participants	45 Participants n=108 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Prior Narcotic use	4 Participants n=56 Participants	3 Participants n=52 Participants	7 Participants n=108 Participants
Chronic Pain	15 Participants n=56 Participants	11 Participants n=52 Participants	26 Participants n=108 Participants
Surgery Length	94.4 minutes STANDARD_DEVIATION 43 • n=56 Participants	95.3 minutes STANDARD_DEVIATION 43 • n=52 Participants	94.8 minutes STANDARD_DEVIATION 42.7 • n=108 Participants
Revision Surgery	19 Participants n=56 Participants	16 Participants n=52 Participants	35 Participants n=108 Participants

PRIMARY outcome

Timeframe: First 7 days after surgery

The average number of narcotic pills needed or used for pain control

Outcome measures

Measure	Norco and Ibuprofen n=56 Participants This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco n=52 Participants This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Narcotic Usage	4.9 Pills Interval 3.6 to 6.3	2.0 Pills Interval 0.9 to 3.1

SECONDARY outcome

Timeframe: Average reported pain for first 7 days after surgery

The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.

Outcome measures

Measure	Norco and Ibuprofen n=56 Participants This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco n=52 Participants This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Patient Pain Level	3.5 Scores on a scale Interval 2.8 to 4.1	2.8 Scores on a scale Interval 2.2 to 3.4

SECONDARY outcome

Timeframe: First 7 days after surgery

The average number of ibuprofen pills needed or used for pain control

Outcome measures

Measure	Norco and Ibuprofen n=56 Participants This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco n=52 Participants This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Ibuprofen Usage	4.5 pills Interval 3.2 to 5.7	7.7 pills Interval 5.8 to 9.6

Adverse Events

Norco and Ibuprofen

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ibuprofen and Norco

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Norco and Ibuprofen n=97 participants at risk This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control	Ibuprofen and Norco n=88 participants at risk This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control
Nervous system disorders Headache	1.0% 1/97 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery	0.00% 0/88 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery
Surgical and medical procedures Drainage from surgical site	1.0% 1/97 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery	1.1% 1/88 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery
Surgical and medical procedures Uncontrolled pain	1.0% 1/97 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery	2.3% 2/88 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery
Gastrointestinal disorders Nausea	1.0% 1/97 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery	0.00% 0/88 • Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery

Additional Information

Khanh Nguyen, MD

Loma Linda University Health System

Phone: 909-558-8558

Email: khanguyen@llu.edu

Results disclosure agreements

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