A prospective double blind randomized comparative study of safety and efficacy of Tapentadol versus Tramadol in post-operative orthopaedic patients

Vasavi Gedela; Sashank Gururaj

doi:10.18203/2319-2003.ijbcp20174796

Authors

Vasavi Gedela Department of Pharmacology, ASRAM medical college, Eluru, Andhra Pradesh, India
Sashank Gururaj Senior Drug Safety Physician, Bio-clinical Safety and Regulatory Solutions, Mysore, Karnataka, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20174796

Keywords:

Chi-square test, Modified Wilson sedation scale, Visual analogue scale

Abstract

Background: Pain following surgery is an unwanted effect which is to be relieved for the better outcome of surgery and anaesthesia. The study was conducted to compare the efficacy and safety of Tapentadol with Tramadol for post-operative pain relief in orthopaedic surgeries.

Methods: After approval of IEC, patients of either sex aged between 18-55 years who had undergone orthopaedic surgeries at Government General Hospital, Kakinada between February 2013 to January 2015 were selected for study. It is a prospective double blind randomised active controlled parallel group comparative study. Sample size is 80 who fulfilled all criteria but there are 6 who discontinued drug in Tramadol group, so 74 were analysed. Written informed consent was taken from all patients, screening, pre anaesthetic evaluation done. Tablet Alprazolam 0.5mg was given at 9PM on previous day of surgery. Both Tramadol and Tapentadol were given 100mg orally 6th hourly. Pain intensity was analysed by visual analogue scale. Sedation was assessed with Modified Wilson sedation scale. Safety and tolerability was assessed by side effects reported by patients. Patients were assessed at 0, 2, 4, 6, 8, 10, 12, 18, 24, 30, 36, 42 and 48 hours post-operatively.

Results: Pain reduction was higher in Tapentadol group on chi square test where p value is less than 0.001.

Conclusions: Both Tramadol and Tapentadol are effective in treatment of post-operative pain. The pain reduction was higher in Tapentadol group on chi-square test where p value is <0.001. So, we can conclude from our study findings that Tapentadol is efficacious compared to Tramadol in reducing Post-operative pain. Both the drugs were well tolerated by the patients.

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Author Biographies

Vasavi Gedela, Department of Pharmacology, ASRAM medical college, Eluru, Andhra Pradesh, India

Assistant Professor, Department of Pharmacology

Sashank Gururaj, Senior Drug Safety Physician, Bio-clinical Safety and Regulatory Solutions, Mysore, Karnataka, India

senior drug safety physician,

bioclinical safety and regulatory solutions

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