Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

University of Florida

Status and phase: Completed; Phase 2

Conditions: Myopia; Photorefractive Keratectomy; Hyperopia

Treatments: Combination Product: oral codeine/acetaminophen; Drug: oral cannabinoid

Study type: Interventional

Funder types: Other

Identifiers

NCT05477875

IRB202201660 -A

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Oral cannabinoid

Experimental group

Description:

Oral cannabinoid

Treatment:

Drug: oral cannabinoid

Oral codeine/acetaminophen

Active Comparator group

Description:

Oral codeine-acetaminophen for controlling pain

Treatment:

Combination Product: oral codeine/acetaminophen