Efficacy of Oral Premedication with Aceclofenac (Immediate and Controlled release) on Post-instrumentation Pain in Root Canal Treatment – A Triple Blind Randomized Controlled Trial

Objective: Patients with moderate to severe preoperative pain have a high incidence of postoperative pain. The objective of this trial was to evaluate the efficacy of oral premedication with aceclofenac (immediate release and controlled release) in the management of post-instrumentation pain in root canal treatment, in patients with moderate to severe preoperative pain.
Methods: Three-arm parallel, triple blinded randomized controlled trial was planned. Patients with moderate to severe endodontic pain, requiring primary endodontic treatment were enrolled. Aceclofenac 100mg- immediate release (aceclofenac-IR), aceclofenac 200mg- controlled release (aceclofenac-CR), and ibuprofen 400mg were compared. The tablets were given one hour before the endodontic procedure. Postoperatively, patients rated their pain at various time points. The duration of pain relief (primary outcome), the intensity of post-instrumentation pain, and the need for additional medicine were calculated. Statistical analysis was done using Kruskal-Wallis followed by Dunn post-hoc, Chi-square tests, and Binominal logistic regression.
Results: Aceclofenac-CR had a statistically significant longest duration of pain relief when compared to ibuprofen (p=0.037) and aceclofenac-IR (p=0.026). The intensity of post-instrumentation pain was lowest in aceclofenac-CR, followed by aceclofenac-IR and ibuprofen. Additional medicine was required for only 8% of patients in Aceclofenac-CR group; whereas for 32% in each of Aceclofenac-IR and Ibuprofen groups. The odds of taking additional medicine were reduced to 0.16 in aceclofenac-CR; increased to 1.05 with age. Conclusion: Aceclofenac-CR had the longest duration of pain relief compared to aceclofenac-IR and ibuprofen. (EEJ-2022-03-037)