title: Efficacy and safety of flupirtine maleate and tramadol hydrochloride in postoperative pain management--a prospective randomised double blinded study.
abstract: The study was conducted to evaluate the efficacy and safety of flupirtine maleate 100 mg thrice daily compared to tramadol hydrochloride 50 mg thrice daily as postoperative pain management for 5 days. A total of 113 postoperative patients were recruited for the study. Those who met the inclusion criteria (n = 104) were randomised into two treatment groups. One of the groups received flupirtine maleate and the other tramadol hydrochloride both orally. The pain intensity was assessed by visual analogue scale. Patients were informed to report any adverse effect encountered during the study period. The overall effect of the drug (global assessment of the study medication) on pain and side-effects was assessed by the patients at the end of the trial on a categorical scale. There was significant reduction in pain score (p < 0.001) in the flupirtine group with almost equal efficacy to that of tramadol group but the incidence of adverse effects were much less (7.4%) and didn't need discontinuation of the study. All drugs were assessed as good. Therefore it can be concluded that oral flupirtine can deliver the same analgesic efficacy as oral tramadol for postoperative pain relief, which might be beneficial for avoiding the adverse effects ofopioids and non-steroidal anti-inflammatory drug therapy.
authors.affiliation: Department of Pharmacology, Calcutta National Medical College, Kolkata 700014
authors.forename: Syed Mohammed
authors.initials: SM
authors.lastname: Naser
authors.forename: Niladri
authors.initials: N
authors.lastname: Sarkar
authors.forename: Arunava
authors.initials: A
authors.lastname: Biswas
authors.forename: Firdaus
authors.initials: F
authors.lastname: Kamal
authors.forename: Raghu
authors.initials: R
authors.lastname: Prakash
authors.forename: Q M
authors.initials: QM
authors.lastname: Rahaman
authors.forename: Anup Kumar
authors.initials: AK
authors.lastname: Das
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000631:Aminopyridines / Q000008:administration & dosage / Q000009:adverse effects; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement / Q000379:methods*; D010149:Postoperative Pain / Q000175:diagnosis / Q000188:drug therapy; D060735:Pharmacovigilance; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000631:Aminopyridines; D000700:Analgesics; D014147:Tramadol; C034161:flupirtine