Comparative Trials
Tramadol versus Codeine
BACKGROUND:
Opioids in combination with acetaminophen (APAP) are often prescribed to Relief moderate pain. As a synthetic analgesic, Tramadol appears to be effective both alone and in combination with APAP.
STUDY OBJECTIVE:
The purpose of this study was to compare the level of effectiveness and the degree of patient toleration for Tramadol/APAP tablets as against codeine/APAP capsules.
DESIGN:
A four-week, randomized, double-blind, parallel-group, active-control, double-dummy, multicenter trial.
PATIENTS:
462 patients (mean age, 57.6 years) with112 (24%) presenting with chronic nonmalignant low back pain, 162 (35%) with osteoarthritis (OA) pain, and 188 (41%) reporting both. |
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INTERVENTIONS:
The patients were assigned at random to treatment using Tramadol/APAP (37.5 mg/325 mg) or codeine/APAP (30 mg/300 mg). After the first daily dose each week, researchers asked the patients to rate:
- the pain relief on a scale where 0 = none and 4 = complete; and
- the pain intensity on a scale where 0 = none and 3 = severe.
This inquiry was made 30 minutes after the initial dose and then hourly for the next six hours. The patients and researchers both made an assessment of the medication’s effectiveness on a scale where 1 = poor and 5 = excellent, and patients kept a diary to record their doses of the studied and any rescue medications.
RESULTS:
67% of the patients received Tramadol/APAP and 33% received codeine/APAP. In the two treatment groups, the equivalent mean doses were 3.5 tablets or capsules daily and the maximum daily doses were 5.5 tablets or 5.7 capsules.
The relief of pain had a rapid onset and lasted for six hours with both medications. The scores for total pain relief for Tramadol/APAP were 11.9 and for codeine /APAP were 11.4. The figures were also comparable in the sum of pain intensity differences with 3.8 for Tramadol/APAP and 3.3 for codeine. Both groups of patients and the researchers assessed effectiveness, producing a mean score 2.9 among all parties with a mean score from the patients at 3.0 for Tramadol/APAP and 2.9 for codeine/APAP. More patients reported adverse side-effects when using codeine/APAP, 24% somnolence and 21% constipation, while 11% of the patients using Tramadol/APAP reported headaches.
CONCLUSION:
This study suggests that both Tramadol/APAP tablets (37.5 mg/325mg and codeine/ APAP capsules (30 mg/300 mg) are effective and patients using Tramadol have fewer adverse side-effects.
