Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Giving post photorefractive keratectomy for pain relief.
- Who it may be relevant to
- Registry conditions: Pain After Photorefractive Keratectomy, VAS Will be Used to Assess Pain Postoperative. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
Overview
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.
Detailed 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
Interventions
- Drug Giving 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.
Primary outcome measures
- Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours. [Time frame: 72 hours postoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Research Institute of Ophthalmolgy — Giza
Identifiers
NCT: NCT06752486 · 25-2-23-3-6