Postoperative Pain Management in Rhinoplasty
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|ClinicalTrials.gov Identifier: NCT03584152|
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : June 28, 2019
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .
Additionally, the study will also seek to track:
- The total number of pills each patients consume from the prescribed 5 day regimen.
- Any associated side effects.
- Additional pain medications prescribed in case of inadequate pain control, postoperatively.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Norco 5Mg-325Mg Tablet Drug: Tylenol 325Mg Caplet Drug: Ibuprofen 200 mg||Phase 2|
From this study, the investigators hope to learn the following:
- Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
- If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
- What are the common side effect profiles of the included drugs?
In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: DRUG ARM A
Norco 5Mg-325Mg Tablet, administered orally every 4 hours for 5 days total
Drug: Norco 5Mg-325Mg Tablet
Active Comparator: DRUG ARM B
Tylenol 325Mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
Drug: Tylenol 325Mg Caplet
Non opioid analgesics
Other Name: Acetaminophen
Drug: Ibuprofen 200 mg
Non opioid analgesics
- Pain intensity Visual Analog Scale (VAS)- 0-100 (0- no pain and 100- most severe pain) [ Time Frame: 5 days ]Self reported pain intensity at every prescribed dose for a period of 5 days.
- Side effects of pain medications [ Time Frame: 5 days ]Self reported side effects of prescribed medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584152
|United States, California|
|Facial Plastic and Reconstructive Surgery Clinic|
|Stanford, California, United States, 94305|
|Principal Investigator:||SAM P Most, MD||Stanford University|