Nevein Kamal Ghamry1, Ahmed Said Ali2, Mohammad Abrar Shareef3, Abdulhadi A AlAmodi4, Mohamed Hamza1, Ahmed M Abbas5, Hammad Ali Fadlalmola6, Mahmoud Alalfy7,8, Ahmed Omar Mahmoud9, Yomna Islam1. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt. 2. Department of Histology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt, ahmedsaidali987@gmail.com. 3. Department of Family Medicine, Sebasticook Valley Hospital, Pittsfield, Maine, USA. 4. Department of Epidemiology and Biostatistics, School of Public School, Jackson State University, Jackson, Mississippi, USA. 5. Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt. 6. Nursing College, Taibah University, Medina, Saudi Arabia. 7. Reproductive Health and Family Planning Department, National Research Centre, Giza, Egypt. 8. Algezeera Hospital, Giza, Egypt. 9. Department of Anesthesiology and Intensive Care Unit, Faculty of Medicine, Assiut University, Assiut, Egypt.
Abstract
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.
RCT Entities:
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.