Post-operative Pain ControlPhase 4NCT04399122
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
A Phase 4 study testing acetaminophen/codeine vs acetaminophen/oxycodone in people with Post-operative Pain Control, run by 59th Medical Wing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain Control
- What is being tested?
- acetaminophen/codeine vs acetaminophen/oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 28 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Warfighter Refractive Surgery Center at WHASC
San Antonio, Texas, 78236
About this study
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.
Read the 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 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.
- Conditions
- Post-operative Pain Control
- Being tested
- acetaminophen/codeine vs acetaminophen/oxycodone
- Keywords
- Photorefractive Keratectomy, Post-operative Eye Pain, Refractive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen/codeine vs acetaminophen/oxycodoneDrug
Also called Tylenol 3 VS Percocet
pain medications
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen with codeine | Active comparator | 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. Receives: Drug: acetaminophen/codeine vs acetaminophen/oxycodone |
| Acetaminophen with oxycodone | Active comparator | oxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. Receives: Drug: acetaminophen/codeine vs acetaminophen/oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Average Pain Score
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
Measured: 2 days post surgery
Secondary outcomes (1)
Post-operative Uncorrected Visual Acuity Right and Left Eye
Right and left eye uncorrected visual acuity at post-operative month 6.
Measured: Post-operative month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start21 Mar 2017
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to Group 1 or Group 2
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Charisma Evangelista, 59th Medical Wing
- Investigators
- Charisma B Evangelista, MD, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399122
- Sponsor's protocol ID
- FWH20160007H
- Status last verified
- Sep 2021
- First submitted
- 19 May 2020
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
- ClinicalTrials.gov ID
- NCT04399122
- Acronym / sponsor ID
- FWH20160007H
- Conditions
- Post-operative Pain Control
- Keywords
- Photorefractive Keratectomy, Post-operative Eye Pain, Refractive Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 5 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to Group 1 or Group 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen with codeine | Active comparator | Drug: acetaminophen/codeine vs acetaminophen/oxycodonecodeine 30mg/acetaminophen 325mg Take one to two tablets every 4 to 6 hours as needed for pain for up to 4 days following surgery. |
| Acetaminophen with oxycodone | Active comparator | Drug: acetaminophen/codeine vs acetaminophen/oxycodoneoxycodone 5mg/acetaminophen 325mg Take one tablet every 4 to 6 hours as needed for pain for up to 4 days following surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophen/codeine vs acetaminophen/oxycodoneAlso: Tylenol 3 VS Percocetpain medications | Drug | Acetaminophen with codeine, Acetaminophen with oxycodone |
Primary outcome
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
1 secondary outcome
Post-operative Uncorrected Visual Acuity Right and Left Eye
Time frame: Post-operative month 6.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charisma B Evangelista, MD principal investigator
59th Medical Wing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen/codeine vs acetaminophen/oxycodone in people with Post-operative Pain Control, run by 59th Medical Wing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Average Pain Score (time frame: 2 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.