Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study

Research Institute of Ophthalmology, Egypt

Status and phase: Enrolling; Phase 1

Conditions: VAS Will be Used to Assess Pain Postoperative; Pain After Photorefractive Keratectomy

Treatments: Drug: Giving post photorefractive keratectomy for pain relief

Study type: Interventional

Funder types: Other

Identifiers

NCT06752486

25-2-23-3-6

Details and patient eligibility

About

The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.

Full description

To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 years old
• preoperative stable refraction for at least one-year,
• normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.

Exclusion criteria

• Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
• amblyopic patients,
• patients with a history of previous ocular surgeries,
• herpetic eye infection, or corneal dystrophies.
• Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
• Diabetics,
• Hypertensives,
• Kidney problems,
• breathing problems
• Adults older than 65 years.
• Previous allergy or adverse reaction to the used drugs.
• History of drug abuse or alcohol abuse problems
• History of mood problems, depression suicidal thoughts or behavior

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Gabapentin Group

Active Comparator group

Description:

The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours

Treatment:

Drug: Giving post photorefractive keratectomy for pain relief

Diclofenac potassium Group

Active Comparator group

Description:

the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative. All patients will be subjected to: 1. History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences. 2. Examination including assessment of vital data (heart rate, blood pressure, respiratory rate, level of consciousness, and respiratory examination.

Treatment:

Drug: Giving post photorefractive keratectomy for pain relief