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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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06752486
Enrollment
64
Registered
2024-12-30
Start date
2024-12-01
Completion date
2025-06-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After Photorefractive Keratectomy, VAS Will be Used to Assess Pain Postoperative

Brief 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.

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

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.

Sponsors

Research Institute of Ophthalmology, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.72 hours postoperativepain assessment using Visual Analogue Scale

Countries

Egypt

Contacts

Primary ContactDina Moustafa M Ali, MD
dina.moustafa.ali@gmail.com01113981021
Backup ContactMohamed Tarek Ahmed El- Naggar, MD- FRCS
drtarekelnaggar@hotmail.com01222158593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026