N/A
N=130
A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01097577 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Clinical Efficacy — 0.89; 1.33; 7.56; 10.34 units on a scale — p=0.180
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- 59th Medical Wing
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Efficacy |
0.89; 1.33; 7.56; 10.34; 6.32; 10.22 | 0.180 |
| SECONDARY PPI Score |
0.03; 0.03; 0.69; 0.84; 0.67; 0.89 | 0.207 |
| SECONDARY Total MPQ Score |
0.15; 0.16; 1.85; 2.18; 1.79; 2.16 | 0.283 |
| SECONDARY Quality of Life - BPI |
0.51; 0.24; 3.76; 4.67; 0.13; 0.08 | 0.223 |
| SECONDARY Clinical Efficacy 2 |
0.81; 0.94; 1.7; 2.44; 1.7; 2.56 | 0.311 |
| SECONDARY Epithelial Healing Time |
3; 2.9; 3.09; 2.9 | 0.581 |
Summary
The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.
Eligibility Criteria
Inclusion Criteria
- Healthy ocular status
- Stable preoperative refractive anisometropia
- Consented to the PRK surgical procedure
Exclusion Criteria
- Pregnant or breastfeeding
- Diagnosed with autoimmune disease or diabetes
- Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
- Patients only desiring PRK on one eye
- Patients with history of drug use/abuse/addiction
- Patients who are on chronic pain medications
- Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
- Patients with a history of suicidality
- Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure
Data sourced from ClinicalTrials.gov (NCT01097577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.