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RecruitingPhase 1NCT06752486

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

Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard

Sponsor

Research Institute of Ophthalmology, Egypt

Enrollment

64 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pain After Photorefractive KeratectomyVAS Will be Used to Assess Pain Postoperative

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria13

  • 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

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Interventions

DRUGGiving post photorefractive keratectomy for pain relief

We plan to conduct a randomized prospective study to assess the efficacy and safety of oral Gabapentin versus oral Diclofenac Potassium for postoperative analgesia in adults undergoing surface ablation. The first group will be given gabapentin orally in a dose of 300mg Tid for 72 hours and 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.

Locations(1)

Research Institute of Ophthalmolgy

Giza, Egypt

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NCT06752486