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

Abstract

<b><i>Introduction:</i></b> Many pharmaceutical, surgical, and complementary medical interventions are used for primary dysmenorrhea treatment. However, no consensus has been reached about the most effective intervention. <b><i>Objective:</i></b> To compare the efficacy and safety of IV tramadol versus IV paracetamol in relieving acute pain of primary dysmenorrhea. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> Pain scores were significantly lower in the tramadol group compared with the paracetamol group at 15, 30, 60 min, and 2 h (<i>p</i> < 0.001). Fewer patients in the tramadol group needed rescue analgesics compared with the paracetamol group (<i>p</i> = 0.04). No significant differences were reported in side effects between both groups. <b><i>Conclusions:</i></b> IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile.

Moxibustion for Primary Dysmenorrhea: An Adjuvant Therapy for Pain Relief

“…Moreover, the current treatment for PD can only alleviate the symptoms in some patients [ 2 ]. Currently, nonsteroidal anti-inflammatory drugs (NSAIDs) seem to be effective in treating PD, but their adverse reactions also pose some health risks [ 3 , 4 ]. Thus, determining a safe and effective therapeutic approach for patients with PD is imperative.…”

Comparison of intravenous paracetamol (acetaminophen) to intravenously or intramuscularly administered non-steroidal anti-inflammatory drugs (NSAIDs) or opioids for patients presenting with moderate to severe acute pain conditions to the ED: systematic review and meta-analysis

“…Included studies’ pain scores ranged from 2.7 to 9.2 (mean 7.6). In 24 trials,9–14 16–30 36–38 the change in pain scores from T0 to T30 was reported, and all trials except one29 reported that all groups (paracetamol, NSAIDs or opioids) achieved clinically significant reductions in pain scores from T0 to T30. Key data were missing from 25 papers, and the lead authors were contacted to request the information,8–32 but no authors replied to requests for data.…”

“…IVP was administered as a single dose of 1 g in 100 mL NS (100 ml normal saline) in 26 trials8–13 15–19 21–30 32 36–38 and at a dose of 15 mg/kg in one trial 20. The infusion rate for the administration of IVP was as a rapid bolus infusion in three trials,11 12 24 slow infusion over 5–20 min in 16 trials,8 10 13 16 18 19 21 22 25 26 29–32 36–38 and not mentioned for 8 trials 9 14 15 17 20 23 27 28. Doses of morphine were 0.1 mg/kg in 12 trials,9 13 19–23 25–28 37 5 mg/mL in 1 trial30 and 10 mg in 2 trials 18 31…”

“…Of the 27 studies included in the review, 20 trials8–13 15 17–21 23–28 32 36 were assessed to have a high or unclear risk of bias, and 7 trials14 16 22 29 30 37 38 were assessed to have a low risk of bias using the ROB V.2 tool. The domains assessed as having some concern or a high risk of bias were randomisation process (22 studies), deviation from intended intervention (19 studies), bias due to missing outcome data (17 studies), bias in the measurement of outcome (18 studies) and bias in the selection of reported outcome (17 studies) (risk of bias table, online supplemental appendix 2).…”

“…After full analysis, 13 trials were excluded (figure 1). Key data were missing from 25 papers, and the lead authors were contacted to request the information 8–32…”