Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial.

INTRODUCTION Many pharmaceutical, surgical, and complementary medical interventions are used for primary dysmenorrhea treatment. However, no consensus has been reached about the most effective intervention. OBJECTIVE To compare the efficacy and safety of IV tramadol versus IV paracetamol in relieving acute pain of primary dysmenorrhea. METHODS This randomized controlled trial was conducted in a tertiary referral hospital and included 100 patients between 18 and 35 years old diagnosed with primary dysmenorrhea. Patients received either 1-g paracetamol or 100-mg tramadol in 100-mL normal saline as an IV infusion over 10 min. Pain intensity was measured by using a visual analog scale at 15, 30, 60 min, and 2 h. We recorded drug side effects and requirements for rescue analgesics. RESULTS Pain scores were significantly lower in the tramadol group compared with the paracetamol group at 15, 30, 60 min, and 2 h (p < 0.001). Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (p = 0.04). No significant differences were reported in side effects between both groups. CONCLUSIONS IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile.