Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-01-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Photorefractive Keratectomy Myopia Hyperopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral cannabinoid

Group Type EXPERIMENTAL

oral cannabinoid

Intervention Type DRUG

dronabinol

Oral codeine/acetaminophen

Oral codeine-acetaminophen for controlling pain

Group Type ACTIVE_COMPARATOR

oral codeine/acetaminophen

Intervention Type COMBINATION_PRODUCT

10 tablets of acetaminophen-codeine combination (300-30mg) without refills.

Interventions

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oral cannabinoid

dronabinol

Intervention Type DRUG

oral codeine/acetaminophen

10 tablets of acetaminophen-codeine combination (300-30mg) without refills.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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dronabinol

Eligibility Criteria

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Inclusion Criteria

* Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
* Consenting to participate

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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes