Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
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|ClinicalTrials.gov Identifier: NCT04399122|
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain Control||Drug: acetaminophen/codeine vs acetaminophen/oxycodone||Phase 4|
This will be a prospective pain assessment study utilizing a simple three question survey given to patients undergoing bilateral PRK. Following recruitment and enrollment (see section 4.1 and 4.2 for recruitment and consent process), patients will be randomized to be prescribed either 1) Group 1: codeine 30mg/acetaminophen 300mg (standard of care dosage) or 2) Group 2: oxycodone 5mg/acetaminophen 325mg (standard of care dosage) post-operatively. All post-operative patients will receive standard bandage contact lenses and as needed tetracaine as per standard of care. Patients will be removed from the study if they take other non-study pain medications. They will be asked to record their pain levels four times daily as well as the number of as needed narcotic pain medication taken and the number of tetracaine drops used (to isolate a potential confounding pain control modality). Randomization will be performed with the aid of www.randomizer.org which will generate a randomized assignment to either group 1 or group 2.
All PRK procedures will be performed per standard of care. The procedure will be performed by one of the 4 approved surgeons. All surgeons will use the same technique using either the VISX or the Allegretto laser machines. This technique will include use of a brush for mechanical removal of corneal epithelial cells. The surgeons will take note at this time of the relative adherence of the epithelium to the underlying tissue and grade the adherence on a scale of 0-4 (0=least adherent and 4=most adherent). In the data analysis, differences between surgeons and between operating platform (VISX vs Allegretto) will be compared to account for any possible bias in operating parameters.
The survey will be worded as follows:
- "Rate your eye pain or level of discomfort at 0800, 1200, 1600 and 2000. Please write the number closest to your response in the table below under the appropriate day and time.
- "How many tablets of study-related pain medication did you take today in the AM/PM?"
- "How many times did you use topical tetracaine today in the AM/PM?"
- "Did you take any other non-study related pain medications?"
Patients will be followed-up post-operatively as per standard of care. This includes follow-up visits at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months. Starting on post-operative day 1, the patients will be asked to record their pain levels using the pain survey at four hour intervals (0800, 1200, 1600, 2000). At the 1 week post-operative visit, the pain surveys will be collected from the patients. Visual acuity data will be extracted from all but the 12 month follow-up appointment and used as a secondary outcome to correlate any possible differences in pain scores to functional outcomes in terms of visual acuity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to Group 1 or Group 2|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Randomization was accomplished by the pharmacy and the medication bottles were not labeled.|
|Primary Purpose:||Supportive Care|
|Official Title:||Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone|
|Actual Study Start Date :||March 21, 2017|
|Actual Primary Completion Date :||October 28, 2019|
|Actual Study Completion Date :||October 28, 2019|
Active Comparator: Acetaminophen with codeine
codeine 30mg/acetaminophen 300mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery.
Drug: acetaminophen/codeine vs acetaminophen/oxycodone
Active Comparator: Acetaminophen with oxycodone
oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery.
Drug: acetaminophen/codeine vs acetaminophen/oxycodone
- Post-operative median daily pain scores [ Time Frame: 1 week after surgery ]The PRK Post-Operative Pain Survey consisted of a scale of 0 - 10 with a score of 0 equal to no pain, a score of 1 - 3 equal to mild pain, a score of 4 - 6 equal to moderate pain and a score of 7 - 10 equal to severe pain
- Post-operative visual acuity [ Time Frame: Post-operative day 1, week 1, and month 1,3 and 6. ]Visual acuity will be tested at each post-operative visit.
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): NCT04399122
|United States, Texas|
|Joint Warfighter Refractive Surgery Center at WHASC|
|San Antonio, Texas, United States, 78236|
|Principal Investigator:||Charisma B Evangelista, MD||59th Medical Wing|