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. MATERIALS AND 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. CONCLUSION: We conclude that oral flupirtine 100 mg is safe and as effective as oral diclofenac sodium 50 mg in reducing postcraniotomy pain.
RCT Entities:
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. MATERIALS AND 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. CONCLUSION: We conclude that oral flupirtine 100 mg is safe and as effective as oral diclofenac sodium 50 mg in reducing postcraniotomy pain.