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The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.
Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status.
Patients scheduled for PRK surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. After the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed Percocet and tetracaine ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10% improvement in pain scores. Secondary outcomes will include measuring healing time, quality of life and use of rescue medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental | Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days |
|
| Placebo | Placebo Comparator | Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | 1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy | Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| PPI Score | Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed with present pain intensity (PPI) score. Scale is 0 (no pain) to 5 (excruciating pain) | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie M Meek, PharmD | 59th Medical Wing | Principal Investigator |
| Charles Reilly, MD | 59th Medical Wing | Study Chair |
| Margaret Bonnie Rosbolt, PharmD, CCRC | 59th Medical Wing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Medical Center - Refractive Surgery Center | Lackland Air Force Base | Texas | 78236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24914779 | Result | Meek JM, Rosbolt MB, Taylor KR, Fusco EA, Panday VA, Reilly CD. Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study. J Ocul Pharmacol Ther. 2014 Sep;30(7):527-32. doi: 10.1089/jop.2013.0208. Epub 2014 Jun 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively. |
| FG001 | Lactose Capsule | Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively. |
| BG001 | Lactose Capsule | Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Efficacy | Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain. | Posted | Mean | Standard Deviation | units on a scale | 5 days |
|
5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation.
Each adverse event reported was monitored daily until resolution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Meek, Clinical Pharmacist | US Air Force | 210-808-2200 | julie.m.meek.mil@mail.mil |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | 1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively. |
|
| Total MPQ Score |
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed using the Total MPQ Score. Scale minimum is 0 (no pain) to maximum of 45 (severe pain). A higher score indicates a worse outcome. |
| 5 days |
| Quality of Life - BPI | Determine if there was an improvement in the patient's functional health and well-being associated with pregabalin compared to standard of care as assessed by Brief Pain Inventory-short form (BPI-SF). Data was assessed on the day of surgery (Day 0) and at the expected peak of pain, postop Day 2 in the morning. Scale is minimum 0 (no pain) to maximum of 10 (pain as bad as you can imagine). A higher score indicates a worse outcome. | 5 days |
| Clinical Efficacy 2 | Determine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin. Total number of doses was collected. A higher number of doses required indicates a worse outcome. | 5 days |
| Epithelial Healing Time | Determine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation. Epithelial defect was measured at post-operative day 3, 5, 7, and 9 in each eye. A higher number of days required for healing indicates a worse outcome. | 5 days or more |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | PPI Score | Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed with present pain intensity (PPI) score. Scale is 0 (no pain) to 5 (excruciating pain) | Posted | Mean | Standard Deviation | score on a scale | 5 days |
|
|
|
|
| Secondary | Total MPQ Score | Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed using the Total MPQ Score. Scale minimum is 0 (no pain) to maximum of 45 (severe pain). A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 5 days |
|
|
|
|
| Secondary | Quality of Life - BPI | Determine if there was an improvement in the patient's functional health and well-being associated with pregabalin compared to standard of care as assessed by Brief Pain Inventory-short form (BPI-SF). Data was assessed on the day of surgery (Day 0) and at the expected peak of pain, postop Day 2 in the morning. Scale is minimum 0 (no pain) to maximum of 10 (pain as bad as you can imagine). A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 5 days |
|
|
|
|
| Secondary | Clinical Efficacy 2 | Determine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin. Total number of doses was collected. A higher number of doses required indicates a worse outcome. | Posted | Mean | Standard Deviation | Rescue medication doses | 5 days |
|
|
|
|
| Secondary | Epithelial Healing Time | Determine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation. Epithelial defect was measured at post-operative day 3, 5, 7, and 9 in each eye. A higher number of days required for healing indicates a worse outcome. | Posted | Mean | Standard Deviation | Days | 5 days or more | eyes | eyes |
|
|
|
|
| 0 |
| 67 |
| 29 |
| 67 |
| EG001 | Lactose Capsule | Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively. | 0 | 62 | 13 | 62 |
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness/Lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Rhinorrhea/congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Postop day 1 morning |
|
| Postop day 1 evening |
|
| Postop day 2 morning |
|
| Postop day 2 evening |
|
| Postop day 3 morning |
|
| Postop day 3 evening |
|
| Postop day 4 morning |
|
| Postop day 1 morning |
|
| Postop day 1 evening |
|
| Postop day 2 morning |
|
| Postop day 2 evening |
|
| Postop day 3 morning |
|
| Postop day 3 evening |
|
| Postop day 4 morning |
|
| Pain at its Least, Day 0 |
|
| Pain at its least, Day2 |
|
| Avg Pain, Day0 |
|
| Avg Pain, Day2 |
|
| Pain Interference, Day0 |
|
| Pain Interference, Day2 |
|
| Postop Day 3 |
|
| Postop Day 4 |
|
| 0.307 |
| Superiority |