In a controlled crossover study, "identical" surgical procedures, the prophylactic removal of bilateral non-erupted 3rd molar teeth, were performed on two separate occasions in 24 healthy patients. Prior to each procedure, either betamethasone 9 mg (Celeston Chronodose) or placebo was administered intramuscularly, in a randomized fashion. Objective and subjective assessments were recorded for paired comparison of the post-operative course, including swelling, pain, trismus, local temperature, bleeding, wound-healing and preference for treatment. In 23 patients, less swelling occurred when betamethasone was given pre-operatively. The mean reduction on the 3rd and 6th post-operative days was 55% (p less than 0.001) and 69% (p less than 0.001), respectively. Pain assessments (visual analogue scale) were significantly lower after the corticosteroid injection; mean response: 1st evening 17 vs 56 mm, 2nd evening 5 vs 37 mm, and 3rd evening 2 vs 13 mm. No significant correlation between the steroid-induced reduction in swelling and pain could be made. This may indicate that dissociation may exist between pain and other inflammatory events like swelling. No clinically apparent infection or other disturbance of wound-healing was noted after corticosteroid administration. This treatment course was preferred by 23 of the 24 patients.
In placebo-controlled cross-over trials in dogs, two 'identical' operations were performed on the forelimbs of each animal with an interval of 28 days, to evaluate how daily doses of 1.5 g paracetamol, 1.5 g acetylsalicylic acid (ASA) and 0.5 g ASA might modulate an acute post-operative inflammatory reaction. On the third post-operative day the reductions in swelling compared with placebo averaged 33% with 1.5 g paracetamol (P = 0.02), 24% with 1.5 g ASA (P = 0.03) and 15% with 0.5 g ASA (P = 0.18); while the reductions in pain estimates averaged 47% with 1.5 g paracetamol (P = 0.01), 32% with 1.5 g ASA (P = 0.07) and 28% with 0.5 g ASA (P = 0.21). There were no clinical signs of adverse drug effects, such as vomiting, haematochezia, cyanosis or depression. The results disagree with the traditional view that paracetamol has little or no anti-inflammatory effect, and demonstrate that paracetamol may reduce an acute inflammatory reaction, at least as efficiently as ASA. The potential pro-inflammatory effect of ASA in low doses is discussed. It is concluded that paracetamol appears to be a valuable drug against post-operative or post-traumatic sequelae in the veterinary as well as in the human clinic.
It was considered that double-blind crossover studies of therapeutic efficacy after acute injury could well be done in patients who required surgical removal of impacted wisdom teeth from both sides of the lower jaw. In the present trial 24 healthy patients received either placebo or ibuprofen (Brufen: 400 mg three times daily), a non-steroidal anti-inflammatory agent, for 5 days commencing the day before surgery. Treatments were given on the two occasions when impacted wisdom teeth were to be removed from one side or other of the lower jaw. A number of objective and subjective parameters were recorded for paired comparison of the post-operative courses, including swelling, trismus and pain. A mechanical device which allows simple and accurate measurement of cheek swelling is described. On the 1st, 3rd and 5th post-operative days in the ibuprofen group the measured swelling averaged 93, 89 and 82%, respectively, of that in the placebo group; the corresponding alpha-values were 0.35, 0.06 and 0.07. Patients with less swelling after ibuprofen were not always those with a high serum concentration of the drug. Ibuprofen significantly reduced pain on the day of the operation. This may at least partly account for less trismus and the preference of the patients for their post-operative courses with ibuprofen. Examination of various haematological parameters did not reveal any significant difference between the two operations. Subjective scores indicated that neither wound-healing nor bleeding was affected by ibuprofen, nor were any side effects detected.
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