Comparative Evaluation of the Efficacy of Two Different Analgesics on Postoperative Pain after Root Canal Treatment: A Randomised Controlled Trial

International Journal of Dental Science and Innovative Research (IJDSIR) IJDSIR : Dental Publication Service Available Online at:www.ijdsir.com Volume – 8, Issue – 5, September – 2025, Page No. : 97 - 103 Corresponding Author: Dr. Yogesh V. Rathod, ijdsir, Volume – 8 Issue - 5, Page No. : 97 - 103 Page97 ISSN: 2581-5989 PubMed - National Library of Medicine - ID: 101738774 Comparative Evaluation of the Efficacy of Two Different Analgesics on Postoperative Pain after Root Canal Treatment: A Randomised Controlled Trial 1Dr. Yogesh V. Rathod, Assistant Professor, Government Dental College and Hospital, Nagpur 2Dr. Harshali Patil, Fellowship Student, Government Dental College and Hospital, Nagpur 3Dr. Shubha Hegde, Assistant Professor, Government Dental College and Hospital, Nagpur 4Dr. M. Shanmuga Priya, Assistant Professor, Government Dental College and Hospital, Nagpur Corresponding Author: Dr. Yogesh V. Rathod, Assistant Professor, Government Dental College and Hospital, Nagpur Citation of this Article: Dr. Yogesh V. Rathod, Dr. Harshali Patil, Dr. Shubha Hegde, Dr. M. Shanmuga Priya, “Comparative Evaluation of the Efficacy of Two Different Analgesics on Postoperative Pain after Root Canal Treatment: A Randomised Controlled Trial”, IJDSIRSeptember – 2025, Volume – 8, Issue – 5, P. No. 97 – 103. Copyright: © 2025, Dr. Yogesh V. Rathod, et al. This is an open access journal and article distributed under the terms of the creative common’s attribution non-commercial License. Which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given, and the new creations are licensed under the identical terms. Type of Publication: Case Series Conflicts of Interest: Nil Abstract Background: Postoperative pain remains a common challenge in endodontics, often indicating treatment failure. Preoperative analgesic strategies, particularly NSAID combinations, are employed to mitigate postinstrumentation discomfort. This study evaluates and compares the analgesic efficacy of Aceclofenac plus Paracetamol versus Ibuprofen plus Paracetamol in managing postoperative pain following root canal treatment. Materials and Methods: This randomized controlled trial included 36 patients with symptomatic irreversible pulpitis, randomly assigned to two groups. Group 1 received Aceclofenac (100 mg) with Paracetamol (500 mg), while Group 2 received Ibuprofen (400 mg) with Paracetamol (500 mg). Standard endodontic procedures were performed under local anesthesia and rubber dam isolation. Postoperative pain was assessed using the Visual Analog Scale (VAS) on Day 1 and Day 4. Data were analyzed using independent-sample t-tests, with a significance level set at p<0.05. Results: The preoperative VAS scores were comparable between groups (p=0.262). At 24 hours, the Ibuprofen + Paracetamol group showed a significantly greater reduction in pain (p=0.0014). By Day 4, pain scores continued to decline in both groups, with the Ibuprofen combination maintaining a statistically significant advantage (p=0.0456). The findings indicate that the Ibuprofen-Paracetamol combination provides superior and sustained analgesic effects compared to AceclofenacParacetamol. Conclusion: The combination of Ibuprofen with Paracetamol demonstrates enhanced early and prolonged postoperative analgesia in endodontic patients, Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 Page98 supporting its clinical utility in managing post-treatment pain. Further research is warranted to explore the underlying mechanisms and long-term outcomes. Keywords: Aceclofenac, Ibuprofen, Post-operative pain, Root canal treatment. Introduction Posttreatment pain remains a prevalent challenge in endodontic practice, frequently serving as an indicator of treatment failure. The incidence of pain following root canal therapy varies significantly, with reported prevalence rates ranging from 10.6% to 82.9%1,2. To mitigate post-instrumentation discomfort, clinicians utilize various pharmacological strategies, including preoperative oral medications, nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, centrally acting analgesics, inhaled NSAIDs, and local injections of steroids or anaesthetics3. Among these, preoperative oral NSAID administration is considered a straightforward and effective method, primarily targeting the reduction of inflammatory mediators such as prostaglandins involved in pain perception4. Aceclofenac is a potent NSAID belonging to the phenylacetic acid group. Its excellent safety profile makes it more acceptable to patients and promotes better treatment compliance5. Another commonly used NSAID, ibuprofen, acts peripherally and demonstrates significant anti-inflammatory potency through reversible and balanced inhibition of COX-1 and COX-2 enzymes. Its efficacy in managing post-endodontic pain is welldocumented, with strong clinical evidence supporting its use6. The combination of NSAIDs with paracetamol has been shown to enhance analgesic efficacy while minimizing adverse effects7]. However, current endodontic literature lacks comprehensive evaluation of such drug combinations. Hence, the present clinical study was undertaken to assess and compare the analgesic efficacy of two pharmacological agents (Aceclofenac +paracetamol and Ibuprofen+ paracetamol) in alleviating postoperative pain following root canal treatment in patients with symptomatic irreversible pulpitis. Materials and Methods The manuscript of this Randomized Controlled Trial has been written according to the Preferred Reporting Items for Randomized Trials in Endodontics (PRIRATE) 2020 guidelines (Figure 1) Figure 1: PRIRATE flowchart of the study Ethical approval and sample size determination: This randomized controlled trial was conducted in the Dental College and Hospital after gaining approval from Institutional Ethics Committee (IEC/GDCHN/40/2024). The study was registered in the clinical trial registry of India. Sample size was calculated using data from study by Parirokh et al 8 with a formula incorporating alpha error (1.96), beta error (0.84), resulting in approximately 18 samples per group. Sample selection Sampling was conducted using the convenience method. The study included healthy individuals aged 18–60 years Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 Page99 with single-rooted vital teeth, complete root formation, and a diagnosis of symptomatic irreversible pulpitis. Exclusion criteria comprised multirooted or non-vital teeth, systemic illness, recent antibiotic or NSAID use, medication allergies, contraindications to lignocaine or apex locator use, latex allergy, pregnancy, lactation, immature roots, root resorption, calcified canals, facial swelling, tenderness on percussion, periapical lesions, TMJ disorders, systemic infections, and immunocompromised status. Eligible patients were informed about the study and enrolled after providing written consent. Study Intervention A comprehensive case history was obtained for all selected patients. Clinical assessment focused on mandibular incisors, canines, and first or second premolars diagnosed with symptomatic irreversible pulpitis. Pulp vitality was tested preoperatively using an electric pulp tester (C Pulse, Foshan Coxo, China), and radiographic evaluation (Carestream Dental India Pvt Ltd) was performed to assess periapical status. Local anesthesia with Lignocaine containing 1:80,000 adrenaline (Xicaine, ICPA Health) was administered. Rubber dam isolation (Hygienic, Coltene, India) was applied, and access cavities were prepared using Endo Access Bur size 2 (Dentsply Sirona) under continuous water irrigation. Pulp tissue was removed using a broach (Mani Inc., Japan), and working length was established with stainless steel K-files ( Mani Inc., Japan) and verified with an apex locator (J. Morita Co., Tustin, CA), as well as confirmed radiographically. The working length was re-verified throughout the procedure. Initial hand instrumentation was performed up to size 20 K-file, followed by canal preparation with Protaper Gold rotary files (F2 or F3 – 20/0.06 or 25/0.06) as per manufacturer’s guidelines, using an electric endomotor (Orikam). Throughout instrumentation, canals were irrigated with 10 mL of 3% sodium hypochlorite (NaOCl) (Prime Dental Products Pvt. Ltd., India), delivered using RC Twents (Prime Dental). Following irrigation, canals were dried with paper points (Diadent, Korea) and obturated using gutta-percha (Diadent, Korea) and AH Plus sealer (Dentsply Maillefer, Germany). Access cavities were then restored with direct composite resin (Ivoclar Vivadent). Postoperatively, all patients were provided with a Visual Analog Scale (VAS) form. Group 1 received an Aceclofenac-paracetamol combination, while Group 2 received an Ibuprofen-paracetamol combination. Followup assessments were conducted on Day 1 and Day 4 after treatment. Pain intensity (both verbal and numerical via VAS) and the number of analgesic tablets consumed were recorded in the patient's chart. The collected data was entered into a Microsoft Excel spreadsheet and subjected to statistical analysis Statistical analysis The VAS data was analyzed-using independentsample T-test to compare the incidence of pre and postoperative pain at all the time intervals amongst the two groups. Differences were considered significant when probabilities were <0.05. Results Demographic data of participants was analyzed. Mean of age for participants in group I was 45.38±10.79 and group II was 42.33±8.01., group I consisted of 6 female and 12 male whereas group II consisted of 5 male and 13 female. The pre-operative mean VAS score was 5.77 ± 1.27 in the Aceclofenac+Paracetamol group and 5.27 ± 1.36 in the Ibuprofen+Paracetamol group. The difference was Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 Page100 not statistically significant (p = 0.262), indicating that both cohorts experienced comparable levels of baseline pain, thereby allowing for an unbiased assessment of the analgesic efficacy during the postoperative period. The results from the 24-hour follow-up demonstrate that both treatment groups experienced a significant reduction in postoperative pain, with the Ibuprofen plus Paracetamol group showing a notably greater decrease compared to the Aceclofenac group. The statistical significance (p = 0.0014) underscores the superior early analgesic effect of the combination therapy, likely attributable to the synergistic action of both drugs in mitigating pain pathways. By the fourth postoperative day, pain scores continued to decline in both groups, yet the Ibuprofen + Paracetamol group maintained a statistically significant advantage (p = 0.0456). This sustained reduction suggests that the combination not only provides effective immediate relief but also offers prolonged analgesic benefits during the recovery phase. The findings support the clinical utility of Ibuprofen combined with Paracetamol for managing postoperative pain, potentially leading to improved patient comfort and satisfaction during recovery. Further research could explore the underlying mechanisms contributing to this sustained efficacy and evaluate longterm outcomes. (Table 1 and Graph 1) Table 1: VAS of Pre-Operative, 24 Hrs Follow-Up and 4 Days Follow Up Of Study Groups. *means statistically significant p<0.05. Graph 1: VAS of Pre-Operative, 24 Hrs Follow-Up and 4 Days Follow Up of Study Groups Discussion Endodontic therapy encompasses the management of pre, intra-, and post-operative symptoms, with post-obturation pain recognized as a potential complication that may become chronic. This pain is associated with factors such as preoperative pain, periapical infection, retreatment procedures, intracanal medicaments, and iatrogenic damage to periapical tissues9,10.A likely explanation for the post obturation pain is the amplification of preexisting inflammatory responses and peripheral sensitization3. Therefore, implementing supplementary approaches to manage post-obturation pain in these patient groups may prove advantageous, which Time Point Group Mean Pain score Std Dev t-Statistic Degrees of Freedom p-Value Pre-operative Aceclofenac+Paracetamol 5.77 ±1.27 1.14 33.84 0.262 Ibuprofen+Paracetamol 5.27 ±1.36 24 hrs Aceclofenac+Paracetamol 1.611 ±0.48 3.48 33.04 0.0014* Ibuprofen+Paracetamol* 1.00 ±0.57 4 days Aceclofenac+Paracetamol 0.44 ±0.59 2.10 25.72 0.0456* Ibuprofen+Paracetamol* 0.11 ±0.31 Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 Page101 subsequently influenced the inclusion criteria for this study. Ibuprofen is a derivative of propionic acid and functions as a non-selective inhibitor of cyclooxygenase (COX) enzymes. In contrast, aceclofenac is a derivative of phenylacetic acid that selectively inhibits COX-2 and the synthesis of prostaglandin E2 (PGE2) in blood mononuclear and polymorphonuclear cells11. According to the existing literature, the combination of ibuprofen and paracetamol, accounting for 34.3% of prescriptions, constitutes the most prevalent analgesic regimen in India12. This preference is primarily attributable to ibuprofen's favorable safety profile, cost-effectiveness, and its demonstrated efficacy in providing potent analgesic and anti-inflammatory effects in the management of postoperative pain consequent to endodontic therapy13. Conversely, aceclofenac is recognized for its superior tolerability among NSAIDs, characterized by a markedly reduced incidence of gastrointestinal adverse effects14. Although combination drug therapies have gained considerable popularity, there is a limited body of published research concerning their efficacy in postoperative management. Therefore, this study has been undertaken to systematically investigate and address this gap in the literature. The study conducted by Syed et al. identified several factors that significantly influenced the post-obturation pain experience, including age, gender, arch, and the presence of pre-operative pain. To establish a baseline for the current investigation, these factors were considered, ensuring that there were no statistically significant differences among them. This approach was employed to facilitate an accurate assessment of the analgesic efficacy without confounding influences. The study utilized the Visual Analog Scale (VAS) to assess postoperative pain, given that the reliability of VAS as a tool for pain measurement is well-documented and extensively validated in scientific research15. The results from the 24-hour follow-up demonstrate that both treatment groups experienced a significant reduction in postoperative pain, with the Ibuprofen plus Paracetamol group showing a notably greater decrease compared to the Aceclofenac group. The statistical significance (p = 0.0014) underscores the superior early analgesic effect of the combination therapy, likely attributable to the synergistic action of both drugs in mitigating pain pathways. By the fourth postoperative day, pain scores continued to decline in both groups, yet the Ibuprofen + Paracetamol group maintained a statistically significant advantage (p = 0.0456). This sustained reduction suggests that the combination not only provides effective immediate relief but also offers prolonged analgesic benefits during the recovery phase. These results endorse the clinical effectiveness of combining Ibuprofen with Paracetamol for postoperative pain management, which may enhance patient comfort and satisfaction during recovery, consistent with findings reported in previous research16–18. Conclusion Within the limitations of study, the combination of Ibuprofen and Paracetamol provides superior and sustained postoperative pain relief after endodontic treatment compared to Aceclofenac and Paracetamol, improving patient comfort. References 1. Arikatla SK, Chalasani U, Mandava J, et al. Interfacial adaptation and penetration depth of bioceramic endodontic sealers Background : Aim : Materials and Methods : Statistical Analysis Used : Results : Conclusions : 2018; 21: 373–377. 2. Joshi N, Mathew S, George J V., et al. Comparative evaluation of the efficacy of two modes of delivery Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 Page102 of Piroxicam (Dolonex®) for the management of postendodontic pain: A randomized control trial. J Conserv Dent 2016; 19: 301–305. 3. Sundaramurthy JL, Natanasabapathy V, Mahendran K, et al. Efficiency of Immediate and Controlled release of Aceclofenac on Post-instrumentation Pain in Root Canal Treatment – A Triple Blind Randomized Controlled Trial. Eur Endod J 2023; 8: 125–132. 4. Ramachandran A, Khan SIR, Mohanavelu D, et al. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent 2012; 15: 310–314. 5. Legrand E. Aceclofenac in the management of inflammatory pain. Expert Opin Pharmacother 2004; 5: 1347–1357. 6. Teja KV, Ramesh S, Vasundhara KA. Comparative Evaluation of Preemptive and Preventive Analgesic Effect of Oral Ibuprofen in Single Visit Root Canal TreatmentA Prospective Randomised Pilot Study. Eur Endod J 2022; 7: 106–113. 7. AlRahabi MK. Predictors, prevention, and management of postoperative pain associated with nonsurgical root canal treatment: A systematic review. J Taibah Univ Med Sci 2017; 12: 376–384. 8. Parirokh M, Sadr S, Nakhaee N. Comparison between Prescription of Regular or On-demand Ibuprofen on Postoperative Pain after Single-visit Root Canal Treatment of Teeth with Irreversible Pulpitis. J Endod 2014; 40: 151–154. 9. Di Spirito F, Scelza G, Fornara R, et al. Post‐ Operative Endodontic Pain Management: An Overview of Systematic Reviews on Post‐ Operatively Administered Oral Medications and Integrated Evidence‐Based Clinical Recommendations. Healthc; 10. Epub ahead of print 2022. DOI: 10.3390/healthcare10050760. 10. Ali S, Mulay S, Palekar A, et al. Prevalence of and factors affecting post-obturation pain following single visit root canal treatment in Indian population: A prospective, randomized clinical trial. Contemp Clin Dent 2012; 3: 459–463. 11. Jae YC. Immunomodulatory effect of nonsteroidal anti-inflammatory drugs (NSAIDs) at the clinically available doses. Arch Pharm Res 2007; 30: 64–74. 12. Kohli A, Singh S, Podar R, et al. A comparative evaluation of endodontic practice trends in India: ‘The Mumbai study’. Indian J Dent Res 2014; 25: 729–736. 13. de Geus JL, Wambier LM, Boing TF, et al. Effects of ibuprofen compared to other premedication drugs on the risk and intensity of postendodontic pain: A systematic review. Eur Endod J 2018; 3: 123–133. 14. Iolascon G, Giménez S, Mogyorósi D. A review of aceclofenac: Analgesic and anti-inflammatory effects on musculoskeletal disorders. J Pain Res 2021; 14: 3651–3663. 15. Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med 2001; 8: 1153–1157. 16. Abushanab D, Al-Badriyeh D. Efficacy and Safety of Ibuprofen Plus Paracetamol in a Fixed-Dose Combination for Acute Postoperative Pain in Adults: Meta-Analysis and a Trial Sequential Analysis. CNS Drugs 2021; 35: 105–120. 17. Menhinick KA, Gutmann JL, Regan JD, et al. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, Dr. Yogesh V. Rathod, et al. International Journal of Dental Science and Innovative Research (IJDSIR) ©2025 IJDSIR, All Rights Reserved Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 Page103 double-blind, placebo-controlled study. Int Endod J 2004; 37: 531–541. 18. Smith EA, Marshall JG, Selph SS, et al. Nonsteroidal Anti-inflammatory Drugs for Managing Postoperative Endodontic Pain in Patients Who Present with Preoperative Pain: A Systematic Review and Meta-analysis. J Endod 2017; 43: 7–15.