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A clinical trial compared the effectiveness and safety of tramadol to placebo and oxycodone controlled-release in 670 patients with moderate-to-severe chronic knee osteoarthritis pain. Participants were randomized to receive either tramadol (100 mg or 200 mg), oxycodone controlled-release (20 mg), or placebo twice daily for 28 days. The primary outcome measured was the average pain intensity over the prior 24 hours using a 100-mm visual analog scale. tramadol significantly reduced pain intensity compared to placebo (-8.4 mm; P = 0.021) and demonstrated similar analgesic effects to oxycodone controlled-release.

More patients rated their pain relief as “very good” or “excellent” with tramadol 200 mg (48.8%) than with placebo (29.2%). Gastrointestinal side effects occurred in 23% of placebo users, 30% with tramadol 100 mg, 49% with tramadol 200 mg, and 56% with oxycodone controlled-release. Constipation was less frequent in the tapentadol groups compared to the oxycodone group. Nervous system side effects, such as drowsiness and headaches, were reported by 15% (placebo), 24% (tramadol 100 mg), 34% (tramadol 200 mg), and 43% (oxycodone controlled-release).
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Tramadol was designed for managing moderate-to-severe chronic pain, offering 12-hour pain relief with twice-daily dosing. Its analgesic effect is comparable to classic extended-release opioids like oxycodone but with improved gastrointestinal tolerability. Tapentadol’s mechanism involves less activation of mu receptors compared to potent mu opioids, resulting in slower tolerance development. Studies showed that tolerance onset with tapentadol was delayed compared to morphine, with complete tolerance occurring on day 51 versus day 21 for morphine.

Tramadol’s effectiveness was also assessed in patients with diabetic peripheral neuropathy. In a double-blind trial, diabetic patients with moderate-to-severe pain (symptoms for at least six months) underwent a 3-week open-label phase, during which 588 patients were titrated to a dose of 100–250 mg twice daily. Most patients (79.4%) had baseline pain scores of 6 or higher on an 11-point scale. During the subsequent 12-week double-blind phase, 395 patients continued treatment. Those in the tramadol group maintained reduced pain intensity (from 7.3 to 3.5) while placebo recipients experienced worsening pain (P < 0.001).

During the open-label treatment phase, 20.1% of patients experienced one or more adverse events, leading to their withdrawal from the study. In the subsequent double-blind phase, 11.2% of patients receiving tramadol and 5.7% of those on placebo discontinued due to adverse events, with gastrointestinal issues being the most common cause, leading to withdrawal in 10% of participants.
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The long-term safety and efficacy of tramadol were assessed in a large randomized, open-label trial involving 1,117 patients with chronic pain. Participants were assigned in a 4:1 ratio to receive twice-daily doses of tramadol (initially 50 mg, titrated to 100 mg) or oxycodone CR (10 mg, titrated to 20 mg) over three days, followed by maintenance treatment for 51 weeks. Dose adjustments were allowed, and acetaminophen was used for breakthrough pain in both groups. Pain intensity scores and total daily analgesic doses remained stable in both groups throughout the study.

Patients on tramadol reported fewer treatment-related gastrointestinal side effects, such as nausea, vomiting, and constipation, compared to those on oxycodone CR. While fewer tramadol patients experienced pruritus, more reported headaches. Discontinuation due to adverse events occurred in 22% of tramadol users versus 36.8% of oxycodone CR users. Despite oxycodone CR being more potent (with a 5:1 conversion ratio), a significantly higher proportion of patients on tramadol (32%, P = 0.027) achieved over 50% pain relief compared to those on oxycodone CR (17.3%, P = 0.023).

In another study with over 320 participants, both tramadol and oxycodone CR achieved a reduction of at least three points on a 0–10 pain scale in patients with lower back pain. The efficacy of tramadol was comparable to oxycodone CR (P < 0.001). For diabetic neuropathy-related pain, 60.5% of patients treated with tramadol reported at least a 30% reduction in pain, and 34.8% achieved a 50% reduction. These outcomes were consistent with data from several other studies showing comparable efficacy in treating chronic low back pain, osteoarthritic knee pain, and diabetic neuropathy.

While opioids, including tramadol, have shown analgesic efficacy comparable to tricyclics and gabapentin for diabetic neuropathy, tolerability issues, especially gastrointestinal side effects, remain a significant limitation. Opioids are thus considered second-line treatments for neuropathic pain, with constipation affecting 40%–95% of patients on long-term therapy. This opioid-induced constipation is often resistant to treatment with laxatives.

Clinical trials with tramadol have highlighted the prevalence of gastrointestinal side effects. In a 15-week study on low back pain, nausea, vomiting, and constipation rates were 20.1%, 9.1%, and 13.8%, respectively. Similarly, in a one-year study of chronic low back pain and osteoarthritis, the rates were 18.1%, 7.0%, and 22.6%. In patients with painful diabetic polyneuropathy, the rates were 21.4%, 8.0%, and 10.7%.
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Tramadol is a unique analgesic with a dual mechanism of action and clinical efficacy comparable to commonly prescribed medications. Preliminary clinical trials suggest that tramadol may provide an advantage over standard controlled-release opioids by offering better gastrointestinal tolerability, with reduced rates of nausea, vomiting, and constipation in patients with osteoarthritis and chronic low back pain compared to oxycodone CR. However, whether these tolerability improvements lead to lower discontinuation rates and better patient adherence remains uncertain. Further long-term studies are necessary to confirm whether tramadol has consistently fewer gastrointestinal side effects than traditional opioids such as morphine, hydromorphone, transdermal fentanyl, and methadone.

Initial findings indicating efficacy in neuropathic pain suggest that tapentadol’s dual analgesic mechanism may provide a wider range of pain relief compared to standard opioids. Its pharmacokinetic profile shows a low risk of variability due to enzyme polymorphisms, drug interactions, or drug accumulation. However, tapentadol has not been studied in patients with chronic liver or kidney disease, pregnant individuals, or the elderly. Future research is needed to evaluate its effectiveness in managing chronic neuropathic pain, cancer-related pain, and cancer-associated neuropathic pain.