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Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04399122
Recruitment Status : Completed
First Posted : May 22, 2020
Results First Posted : October 5, 2021
Last Update Posted : October 5, 2021
Information provided by (Responsible Party):
Charisma Evangelista, 59th Medical Wing

Brief Summary:
Photorefractive keratectomy (PRK) is a refractive error correction procedure that helps eliminate or reduce the dependence on corrective lenses. An important aspect of PRK is post-operative pain management. Post-operative pain can be significant in the first three to five days and is typically controlled utilizing various modalities including narcotic pain medication. Simple observation suggests a difference in the post-operative pain levels of patients utilizing the more potent oxycodone- versus the less potent codeine-containing acetaminophen preparations. There have been no studies performed to explore any differences in perceived pain comparing these two medications when used following PRK. This study is designed to answer this question by means of a pain survey conducted in the first five days post-op. This may help better manage similar patients in the future.

Condition or disease Intervention/treatment Phase
Post-operative Pain Control Drug: acetaminophen/codeine vs acetaminophen/oxycodone Phase 4

Detailed Description:

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 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:

  1. "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.
  2. "How many tablets of study-related pain medication did you take today in the AM/PM?"
  3. "How many times did you use topical tetracaine today in the AM/PM?"
  4. "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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acetaminophen with codeine
codeine 30mg/acetaminophen 325mg 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
pain medications
Other Name: Tylenol 3 VS Percocet

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
pain medications
Other Name: Tylenol 3 VS Percocet

Primary Outcome Measures :
  1. Post-operative Average Pain Score [ Time Frame: 2 days post 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

Secondary Outcome Measures :
  1. Post-operative Uncorrected Visual Acuity Right and Left Eye [ Time Frame: Post-operative month 6. ]
    Right and left eye uncorrected visual acuity at post-operative month 6.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • M/F >21 years of age (PRK is not done on anyone under the age of 21 at this surgery center)
  • Have met all criteria for bilateral PRK

Exclusion Criteria

  • Patients who do not meet the criteria for refractive surgery
  • Patients receiving LASIK
  • Patients known to have an allergy to either of the study pain medications
  • Patients receiving refractive surgery on only one eye
  • Pregnant women, children, military basic trainees, prisoners and detainees
  • Subject has used narcotics in the last 6 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT04399122

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United States, Texas
Joint Warfighter Refractive Surgery Center at WHASC
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
59th Medical Wing
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Principal Investigator: Charisma B Evangelista, MD 59th Medical Wing
  Study Documents (Full-Text)

Documents provided by Charisma Evangelista, 59th Medical Wing:
Study Protocol  [PDF] September 6, 2017
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Charisma Evangelista, Chief of Refractive Surgery, 59th Medical Wing Identifier: NCT04399122    
Other Study ID Numbers: FWH20160007H
First Posted: May 22, 2020    Key Record Dates
Results First Posted: October 5, 2021
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Charisma Evangelista, 59th Medical Wing:
Photorefractive Keratectomy
Post-operative Eye Pain
Refractive Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents