title: Evaluating the role of flupirtine for postcraniotomy pain and compare it with diclofenac sodium: a prospective, randomized, double blind, placebo-controlled study.
abstract: BACKGROUND
  Patients undergoing craniotomy, experience moderate to severe pain in postoperative period. Flupirtine does not have side effects like sedation and increase postoperative bleeding, so it may be a useful analgesic in neurosurgical patients. We designed this prospective, randomized, double blind, placebo-controlled study to evaluate the role of flupirtine for postcraniotomy pain and compare it with diclofenac sodium.
  
  
  METHODS
  A total of 390 adults (18 to 70 y), American Society of Anaesthesiologists I and II, of either sex, undergoing elective craniotomy, were randomly divided into 3 equal groups of 130 each. Group 1 (control) received placebo, group 2 (diclofenac) received tablet diclofenac 50 mg, and group 3 (flupirtine) received capsule flupirtine 100 mg. All medications were given 8 hourly on second postoperative day for 48 hours. Visual Analogue Scale score, level of sedation and incidence of side effects were observed.
  
  
  RESULTS
  Nineteen patients were dropped from the study and therefore subsequent analysis was carried out for 371 patients only. There was significant reduction of Visual Analogue Scale score in flupirtine and diclofenac group when compared to control (P<0.0001). Pain relief observed in control, flupirtine, and diclofenac group was 69.8%, 90.2%, and 90.5%, respectively. Need of rescue analgesia was significantly less in flupirtine and diclofenac group as compared to control (P<0.0001). No significant difference was observed among the groups in regards to adverse effects.
  
  
  CONCLUSIONS
  We conclude that oral flupirtine 100 mg is safe and as effective as oral diclofenac sodium 50 mg in reducing postcraniotomy pain.
authors.affiliation: Departments of *Anaesthesiology †Neurosurgery ‡Neuroanaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
authors.forename: Ghanshyam
authors.initials: G
authors.lastname: Yadav
authors.forename: Sujali
authors.initials: S
authors.lastname: Choupoo
authors.forename: Saurabh K
authors.initials: SK
authors.lastname: Das
authors.forename: Susanta K
authors.initials: SK
authors.lastname: Das
authors.forename: Shailaja S
authors.initials: SS
authors.lastname: Behera
authors.forename: Sandeep
authors.initials: S
authors.lastname: Khuba
authors.forename: Lal D
authors.initials: LD
authors.lastname: Mishra
authors.forename: Dinesh K
authors.initials: DK
authors.lastname: Singh
mesh_terms: D000328:Adult; D000368:Aged; D000631:Aminopyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003399:Craniotomy; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D000631:Aminopyridines; D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; C034161:flupirtine