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|Status||Condition||Sponsor/Collaborator(s)||First Received||Last Changed||Verification Date|
|Recruiting||Postoperative Pain||Loma Linda University Other||August 5, 2009||March 27, 2012||March 2012|
|Study Type||Study Design||Phase||Enrollment||Start Date||End Date|
|Interventional||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment||N/A||104||November 2009||-|
|Loma Linda University - Ophthalmology||Loma Linda California 92354 United States||Blen Eshete, MPH(c)||-||firstname.lastname@example.org||Recruiting|
|Drug||Gabapentin||Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days|
|Drug||pregabalin||50 mg PO TID|
|Type||Measure||Time Frame||Safety Issue|
|Primary||Decreased overall pain score as measured by the visual analogue scale||one month||No|
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study.
One hundred and four patients who meet the inclusion criteria undergoing photorefractive
keratectomy (PRK) in one or both eyes will be randomly assigned into one of two treatment
groups via computer. 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. Patients in the gabapentin group will take
300 mg three times a day starting two hours prior to surgery and will continue for a total
of four days. Patients in the pregabalin group will take 50 mg three times a day starting
two hours prior to surgery and will also continue for four days.
Only the refractive surgery coordinator and the patient will know what medication the
patient is taking. The patient will be instructed not to share this information with any
other study participants or their surgeon. The coordinator will keep a list of the patients
ID numbers and the treatments they are receiving.
Prior to surgery, each patient will be taught how to assess their pain level using the
visual analogue scale (VAS), a well documented method of pain assessment. After
surgery the patients will assess their pain levels at different intervals of time - one hour
after surgery, the evening of the surgery, and three times a day for four subsequent days.
Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale
(ESS) and record the presence of dizziness daily for the same amount of time. On the fourth
day they will return to clinic for a post operative appointment. At that time the pain
assessment scales will be collected and analyzed. The patients will return at one month to
further assess long term pain after PRK.
Postoperative pain levels recorded using the visual analogue scales, ESS, and self reported
dizziness assessments will be collected on the fourth postoperative day. These will be
compiled into data sets and analyzed. Data will be compiled into means with lower and upper
quartiles and analyzed using a two-sided t test. The difference in pain levels will be
described throughout the postoperative period to determine if one medication significantly
reduces postoperative pain initially within the first 24 hours, during the interval between
24 hours to four days, and further after surgery (one month postoperatively). Data regarding
levels of somnolence and dizziness will also be reported.
|Gender||Minimum Age||Maximum Age||Healthy Volunteers|
|Both||-||70 Years||Accepts Healthy Volunteers|
- 18 years of age or older
- Undergoing PRK in at least one eye
- 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.
PMID 16625626: Shortt AJ, Allan BD. Photorefractive keratectomy (PRK) versus laser-assisted in-situ keratomileusis (LASIK) for myopia. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005135. Review.
PMID 12759854: Ambrósio R Jr, Wilson S. LASIK vs LASEK vs PRK: advantages and indications. Semin Ophthalmol. 2003 Mar;18(1):2-10. Review.
PMID 11583670: Lee JB, Kim JS, Choe C, Seong GJ, Kim EK. Comparison of two procedures: photorefractive keratectomy versus laser in situ keratomileusis for low to moderate myopia. Jpn J Ophthalmol. 2001 Sep-Oct;45(5):487-91.
PMID 17571652: Van de Pol C, Greig JL, Estrada A, Bissette GM, Bower KS. Visual and flight performance recovery after PRK or LASIK in helicopter pilots. Aviat Space Environ Med. 2007 Jun;78(6):547-53.
PMID 11248818: Walker MB, Wilson SE. Recovery of uncorrected visual acuity after laser in situ keratomileusis or photorefractive keratectomy for low myopia. Cornea. 2001 Mar;20(2):153-5.
PMID 15721716: Sandoval HP, de Castro LE, Vroman DT, Solomon KD. Refractive Surgery Survey 2004. J Cataract Refract Surg. 2005 Jan;31(1):221-33.
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PMID 12218520: Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4.
PMID 12351281: Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents.
PMID 15840990: Pandey CK, Navkar DV, Giri PJ, Raza M, Behari S, Singh RB, Singh U, Singh PK. Evaluation of the optimal preemptive dose of gabapentin for postoperative pain relief after lumbar diskectomy: a randomized, double-blind, placebo-controlled study. J Neurosurg Anesthesiol. 2005 Apr;17(2):65-8.
PMID 15087630: Turan A, Karamanlio?lu B, Memi? D, Hamamcioglu MK, Tükenmez B, Pamukçu Z, Kurt I. Analgesic effects of gabapentin after spinal surgery. Anesthesiology. 2004 Apr;100(4):935-8.
PMID 15271709: Turan A, Memi? D, Karamanlio?lu B, Ya?iz R, Pamukçu Z, Yavuz E. The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. Anesth Analg. 2004 Aug;99(2):375-8, table of contents.
PMID 15845693: Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-9, table of contents.
PMID 18366517: Kavalieratos CS, Dimou T. Gabapentin therapy for painful, blind glaucomatous eye: case report. Pain Med. 2008 Apr;9(3):377-8.
PMID 17718702: Poujois A, Vidailhet M, Trocello JM, Bourdain F, Gaymard B, Rivaud-Péchoux S. Effect of gabapentin on oculomotor control and parkinsonism in patients with progressive supranuclear palsy. Eur J Neurol. 2007 Sep;14(9):1060-2.
PMID 16387013: Rahman W, Proudlock F, Gottlob I. Oral gabapentin treatment for symptomatic Heimann-Bielschowsky phenomenon. Am J Ophthalmol. 2006 Jan;141(1):221-2.
PMID 16732211: Choudhuri I, Sarvananthan N, Gottlob I. Survey of management of acquired nystagmus in the United Kingdom. Eye. 2007 Sep;21(9):1194-7. Epub 2006 May 26.
PMID 18226799: Nissman SA, Tractenberg RE, Babbar-Goel A, Pasternak JF. Oral gabapentin for the treatment of postoperative pain after photorefractive keratectomy. Am J Ophthalmol. 2008 Apr;145(4):623-629. Epub 2008 Jan 28.
PMID 18716003: Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. Epub 2008 Aug 20.
PMID 19128880: Taylor CP. Mechanisms of analgesia by gabapentin and pregabalin--calcium channel alpha2-delta [Cavalpha2-delta] ligands. Pain. 2009 Mar;142(1-2):13-6. Epub 2009 Jan 6. Review. No abstract available.
PMID 16503325: Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87. Review.
PMID 15596757: Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004 Dec 14;63(11):2104-10.
PMID 15820913: Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005 Apr;6(4):253-60.
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