Assessment of Safety and Efficacy of Gabapentin After Surface Ablation

Phase 1

Recruiting

• Conditions: Pain After Photorefractive Keratectomy; VAS Will Be Used to Assess Pain Postoperative
• Interventions: Drug: Giving post photorefractive keratectomy for pain relief

• Registration Number: NCT06752486
• Lead Sponsor: Research Institute of Ophthalmology, Egypt

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

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-29
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin Group	Giving post photorefractive keratectomy for pain relief	The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours
Diclofenac potassium Group	Giving post photorefractive keratectomy for pain relief	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.	72 hours postoperative	pain assessment using Visual Analogue Scale

Trial Locations

Locations (1)

Research Institute of Ophthalmolgy; 🇪🇬 Giza, Egypt