Publications reporting the clinical use of tramadol are numerous. A number of reviews of the
clinical use of tramadol have also been published.
Intra-operative and Post-operative Analgesia
Comparison with placebo
A pooled analysis of 9 single-dose, double-blind, randomised, placebo-controlled studies
included a total of 1594 patients with post-operative pain following caesarean section or general surgical procedures. Analysis showed that analgesic efficacy of tramadol at doses equal to or greater than 50mg was superior to that of placebo (statistical value not reported). Likewise, pooled analysis of 9 double-blind, randomised studies involving 1859 patients with dental extraction pain evaluated single oral doses of tramadol ranging from 50mg to 200mg. Analysis demonstrated a significantly greater efficacy for tramadol than for placebo at all doses evaluated. (The majority of these studies have not been published.) A subsequent meta-analysis of these 18 studies confirmed the effectiveness of tramadol in comparison with placebo and demonstrated a significant dose response. Multi-dose studies have also demonstrated a superior effect of oral tramadol over placebo in both pain after dental extraction and pain after orthopaedic surgery.
Comparison with morphine
Tramadol (up to 3 doses of 50mg iv) was compared with morphine (up to 3 doses of 5mg iv) over 6
hours in a double-blind, randomised study of 150 patients after gynaecological surgery. In those patients who reported moderate pain, the two drugs were equally effective. However, morphine was
superior in patients starting with severe pain. Respiratory depression (as measured by oxygen
desaturation) occurred in 13% of the morphine group but not at all in the tramadol group. Sedationand nausea were also more common in the morphine group.
Comparison with pethidine
Tramadol was compared to pethidine in 30 patients undergoing gynaecological surgery. Using
patient controlled analgesia during the first 24 hours post-operatively, tramadol was demonstratedto be of equivalent potency to pethidine. Mean 24 hour consumption of tramadol was 642mg (SD190mg, range 180-840mg) and for pethidine 606mg (SD 172mg, range 360-780mg). The estimate of relative potency of tramadol to pethidine was 0.94 (95% CI: 0.72-1.17).
In a randomised study in 50 patients presenting for caesarean section under spinal anaesthesia with lignocaine 25, tramadol 1.5mg/kg was as effective as pethidine 1mg/kg intramuscularly. There was no significant difference in side effects between the two groups, including neonatal APGAR scores.
Chronic Pain
Tramadol has been included as a step 2 analgesic in the second edition of the World Health
Organisation’s recommendations for treatment of cancer pain.
Twenty cancer patients with strong pain unresponsive to previous pain treatment were randomised
to receive oral tramadol or morphine solution in a randomised, double-blind, cross-over study.
Doses were individually titrated and cross-over occurred on day 4. Pain scores were similar on day 4, although pain scores were higher in the tramadol group on days 1 and 2. There was a statistically significant reduction in side-effects (particularly nausea and constipation) with tramadol.
There was no significant difference in analgesic efficacy between the two groups. Antiemetics, laxatives, neuroleptics and steroids were prescribed significantly more frequently in the morphine group; the use of other adjuvants was similar in both groups. Constipation, neuropsychological symptoms and pruritus were observed significantly more frequently with low dose morphine. Other symptoms had similar frequencies in both groups.
Oral tramadol was evaluated in a double-blind study over a 4 week period in 390 patients over 65
years of age with chronic pain due to a variety of conditions. Patients were initially treated with either tramadol 50mg orally or paracetamol/codeine 300mg/30mg and were then allowed to titrate the dose according to pain severity to a total of eight capsules per day. Mean pre-treatment pain intensities were moderate for both groups. At the end of the study, average daily doses were 244mg of tramadol and 1,407mg/140.7mg of paracetamol/codeine.
Both treatments were rated as good, very good or excellent by 55% of patients in each group. There was no significant difference in the incidence of adverse effects in each group, but adverse effects resulted in discontinuation in a significantly higher proportion of patients taking tramadol (18.8% vs 9.6%, p<0.05).
Oral tramadol (100mg eighth hourly) was compared with a fixed dose combination of paracetamol/codeine (1000mg/60mg eighth hourly) in a randomised, double-blind cross-over study
in 55 patients suffering from refractory chronic back pain.Efficacy was similar in the two arms.
Although the combination analgesic was reported by the authors as better tolerated than tramadol, the difference was not statistically significant.
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