AIM: This single-centre randomized, double-blind, placebo-controlled clinical trial assessed the effect of a preoperative, single, oral dose of prednisolone on postoperative pain and postoperative analgesic intake in patients with symptomatic, irreversible pulpitis in mandibular molars. METHODOLOGY:Four hundred participants, randomly assigned to two equal groups, received either 40 mg prednisolone or placebo tablets 30 min before single-visit root canal treatment. Patients recorded their pain level 6, 12 and 24 h after treatment on a 100-mm visual analogue scale. All patients received a sham capsule to take if needed as a postoperative analgesic, and, if the pain persisted, an analgesic was prescribed. The relative risk reduction and 95% confidence intervals (CI) were estimated for binary data. Mann-Whitney U-test was used to compare postoperative pain intensity between groups. RESULTS: The relative risk reduction in pain incidence was 20.31% (95% CI: 12.03%, 27.82%) at 6 h, 23.39% (95% CI: 14.75%, 31.16%) at 12 h and 28.85% (95% CI: 18.08%, 38.20%) at 24 h. Prednisolone had significantly less post-obturation pain intensity compared to placebo at 6, 12 and 24 h (P < 0.001). The relative risk reduction in sham-capsule intake was 54% (95% CI: 38%, 66%) and of analgesic intake was 55% (95% CI: 3%, 79%). No adverse effects were recorded. CONCLUSION: Preoperative oral administration of a single dose of 40 mg prednisolone was beneficial to control short-term post-obturation pain after single-visit root canal treatment in patients with symptomatic irreversible pulpitis reducingpain incidence after 24 h by approximately 30% and postoperative analgesic intake by approximately 55%.
RCT Entities:
AIM: This single-centre randomized, double-blind, placebo-controlled clinical trial assessed the effect of a preoperative, single, oral dose of prednisolone on postoperative pain and postoperative analgesic intake in patients with symptomatic, irreversible pulpitis in mandibular molars. METHODOLOGY: Four hundred participants, randomly assigned to two equal groups, received either 40 mg prednisolone or placebo tablets 30 min before single-visit root canal treatment. Patients recorded their pain level 6, 12 and 24 h after treatment on a 100-mm visual analogue scale. All patients received a sham capsule to take if needed as a postoperative analgesic, and, if the pain persisted, an analgesic was prescribed. The relative risk reduction and 95% confidence intervals (CI) were estimated for binary data. Mann-Whitney U-test was used to compare postoperative pain intensity between groups. RESULTS: The relative risk reduction in pain incidence was 20.31% (95% CI: 12.03%, 27.82%) at 6 h, 23.39% (95% CI: 14.75%, 31.16%) at 12 h and 28.85% (95% CI: 18.08%, 38.20%) at 24 h. Prednisolone had significantly less post-obturation pain intensity compared to placebo at 6, 12 and 24 h (P < 0.001). The relative risk reduction in sham-capsule intake was 54% (95% CI: 38%, 66%) and of analgesic intake was 55% (95% CI: 3%, 79%). No adverse effects were recorded. CONCLUSION: Preoperative oral administration of a single dose of 40 mg prednisolone was beneficial to control short-term post-obturation pain after single-visit root canal treatment in patients with symptomatic irreversible pulpitis reducing pain incidence after 24 h by approximately 30% and postoperative analgesic intake by approximately 55%.