Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy

NCT00954187 | Terminated Results

• 1 other identifier: 59070
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK). Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK. Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented. Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Decreased Overall Pain Score as Measured by the Visual Analogue Scale

  No data was collected or analyzed. No study procedures were performed.

  one month

Study Arms (2)

Gabapentin

EXPERIMENTAL

Neurontin

Drug: Gabapentin

Pregabalin

EXPERIMENTAL

Lyrica

Drug: pregabalin

Interventions

Gabapentin DRUG

Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days

Also known as: Neurontin

Gabapentin

pregabalin DRUG

50 mg PO TID

Also known as: Lyrica

Pregabalin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Undergoing PRK in at least one eye

You may not qualify if:

• Serious medical problems within the last 6 months including myocardial infarction (heart attack), congestive heart failure, stroke, deep vein thrombosis, pulmonary embolism, and other conditions, etc.
• Serious kidney disease as evidenced by the need for dialysis or kidney transplant.
• History of seizure or other neurologic disorders.
• Patients intending to become pregnant or who are pregnant or nursing over the projected course of treatment.
• Currently taking gabapentin or pregabalin for other medical purposes.
• Known allergic reaction to gabapentin or pregabalin from previous use.
• Plans to move out of the area within 8 weeks after the surgery.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University - Ophthalmology

Loma Linda, California, 92354, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Julio Narvaez, MD
• Organization: Loma Linda University

thamilton@llu.edu

9095589408

Study Officials

• Julio Narvaez, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 9, 2017
• Results First Posted: September 25, 2014

Record last verified: 2016-11

Locations

US (1)