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Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.

Authors
  • Ala, Shahram1
  • Alvandipour, Mina2
  • Saeedi, Majid3
  • Mansourifar, Mohaddeseh1
  • Monajati, Mahila1
  • Shiva, Afshin4
  • 1 Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. , (Iran)
  • 2 Department of Surgery, Imam Khomeini General Hospital Affiliated to Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. [email protected] , (Iran)
  • 3 Department of Pharmaceutical Sciences, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. , (Iran)
  • 4 Department of Clinical Pharmacy, Nephrology and Kidney Transplant Research Center, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran. , (Iran)
Type
Published Article
Journal
Journal of Gastrointestinal Surgery
Publisher
Springer-Verlag
Publication Date
Feb 01, 2020
Volume
24
Issue
2
Pages
405–410
Identifiers
DOI: 10.1007/s11605-019-04147-7
PMID: 30783957
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain. In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy. The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days. A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial. This study was conducted at a single educational hospital. The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption. No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group. Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.

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