ABSTRACT
UNLABELLED: BACKGROUND, METHOD: The analgesic efficacy and tolerability of dexketoprofen-trometamol (DKPT) was compared with tramadolhydrochloride (TRAM) in a multicentre, randomised, double-blind, clinical trial in 192 Patients with acute low back pain. The initial pain at rest and on movement should be at least 50 mm on a 100 mm visual analogue scale. The daily dose during the 7 days' treatment was 50 mg TRAM t.i.d. (n = 95) or 25 mg DKPT t.i.d. (n = 97). The patients were allowed to take additional Paracetamol up to 4 x 500 mg per day as rescue medication. RESULTS: From the 4th day of treatment pain on movement decreased significantly (p = 0.044) in the DKPT-group in comparison with the TRAM-group. The nocturnal pain decreased during the treatments with a difference in therapies of 22.9% in favour of DKPT. Within the DKPT-group the patients required additional Paracetamol more often only during the 1st day of treatment whereas the patients of the TRAM-group required the additional rescue medication mainly during the first 3 days of treatment. This difference was statistically significant (p = 0.011). Under DKPT treatment patients experienced significantly less adverse events (with an at least "possible" causal relationship; p = 0.026). This can be explained by central nervous disturbances that occurred only in the TRAM group. The distribution of gastro-intestinal disorders was identical in both treatment groups. CONCLUSION: With this results DKPT in comparison with TRAM also showed to be a strong analgesic drug with a better risk-benefit relation due to its better tolerability.
Subject(s)
Analgesics, Opioid/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Ketoprofen/analogs & derivatives , Ketoprofen/administration & dosage , Low Back Pain/drug therapy , Tramadol/administration & dosage , Tromethamine/analogs & derivatives , Tromethamine/administration & dosage , Adult , Aged , Analgesics, Opioid/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Double-Blind Method , Female , Humans , Ketoprofen/adverse effects , Male , Middle Aged , Pain Measurement , Tramadol/adverse effects , Tromethamine/adverse effectsSubject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Ketoprofen/analogs & derivatives , Ketoprofen/therapeutic use , Low Back Pain/drug therapy , Tromethamine/analogs & derivatives , Tromethamine/therapeutic use , Double-Blind Method , Drug Combinations , Early Ambulation , Humans , Pain MeasurementABSTRACT
A total of 91 children with myelomeningocele and neurogenic bladder were followed up for periods of between five and 10 years. The results of investigations of the upper and lower urinary tracts at the ages of three months, five years and 10 years showed that subvesical obstruction was rare in the infant period but that it increased year by year as the children grew older. By the age of five years 50 per cent of the children in this sample had severe obstructive changes. The study shows that children with neurogenic bladder who reach five or six years of age without developing severe symptoms of progressive subvesical obstruction will stand a good chance of being able to be treated conservatively.
