Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control
Overview
- Phase
- Phase 2
- Intervention
- oral cannabinoid
- Conditions
- Photorefractive Keratectomy
- Sponsor
- University of Florida
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Pain as Recorded by the FACES Scale (Maximum) After First Surgery
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
- •Consenting to participate
- •Not meeting exclusion criteria will be included in the study population.
Exclusion Criteria
- •Patients not candidates for PRK will be excluded from the study.
- •Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.
- •Additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications.
- •Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.
- •Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.
- •Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.
Arms & Interventions
Oral cannabinoid
Oral cannabinoid
Intervention: oral cannabinoid
Oral codeine/acetaminophen
Oral codeine-acetaminophen for controlling pain
Intervention: oral codeine/acetaminophen
Outcomes
Primary Outcomes
Pain as Recorded by the FACES Scale (Maximum) After First Surgery
Time Frame: 1 week after first surgery
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Pain as Recorded by the FACES Scale (Maximum) After Second Surgery
Time Frame: 1 week after second surgery
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
Secondary Outcomes
- Uncorrected Visual Acuity of First Eye Surgery(3 months after first surgery)
- PROWL-SS(3 month)
- Quality of Life Refractive Correction Survey(3 months)
- Ocular Discomfort Questionnaire(3 months)
- Uncorrected Visual Acuity of Second Eye Surgery(3 months after second surgery)