CONSORT Randomized Clinical Trial
Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial

https://doi.org/10.1016/j.joen.2016.12.012Get rights and content

Abstract

Introduction

The present clinical trial aimed to evaluate and compare the effect of a single pretreatment dose of ketorolac (20 mg), prednisolone (30 mg), and placebo on postendodontic pain in patients undergoing endodontic therapy for irreversible pulpitis or pulpal necrosis using a visual analog scale.

Methods

Ninety-two subjects were included in the present trial; 46 subjects had a pulpal diagnosis of irreversible pulpitis, and the other 46 had pulpal necrosis. These subjects were randomly allocated into 1 of the 3 pretreatment medication groups: ketorolac (20 mg), prednisolone (30 mg), or a placebo. The drugs were administered 30 minutes before the procedure followed by a routine single-visit root canal treatment. Preoperative and postoperative pain was evaluated using a visual analog scale at 6 time intervals. A comparison between the different groups was performed using one-way analysis of variance followed by the Tukey post hoc test. A comparison of pain within each group at various time intervals was performed using repeated measures analysis of variance followed by the paired t test and Bonferroni correction.

Results

At the end of 6 hours, in irreversible pulpitis cases, the ketorolac group showed an effective reduction in pain scores compared with the other drugs. At the end of 12 hours, the prednisolone group significantly reduced the pain scores compared with the other drugs.

Conclusions

From this study, it could be concluded that a single pretreatment dose of prednisolone has a more sustained effect in reducing postendodontic pain compared with placebo or ketorolac.

Section snippets

Selection of Subjects

Approval of the study protocol and ethical clearance were obtained from the Institutional Review Board, Bapuji Dental College and Hospital, Davangere, India. A patient information form was given to all enrolled participants, and their informed consent was obtained. The study subjects recruited in this triple-blind, parallel, randomized controlled trial were from the pool of patients selected in the Department of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital.

Sample Size

The

Statistical Analysis

Normality of the data was tested using the Kolmogorov-Smirnov test. Because the data showed normal distribution, parametric tests were used for comparing the means.

Pain experienced by subjects belonging to different drug groups was analyzed using one-way analysis of variance (ANOVA) followed by the Tukey post hoc test. A subgroup analysis between irreversible pulpitis cases and pulpal necrosis cases was performed using the unpaired t test. A comparison of pain (mean VAS scores) within each

Results

There were 42 women and 44 men included in this clinical trial. There were no significant differences between the groups with respect to age, sex, and arch (Table 3). A comparison of pain among the ketorolac, prednisolone, and placebo groups measured by the VAS at different time intervals is shown in Table 4. Preceding endodontic therapy, the baseline pain data showed no significant difference (P > .05) between the 3 premedication groups in both the irreversible pulpitis and pulpal necrosis

Discussion

The present study compared the degree of postendodontic pain in 92 patients undergoing single-visit endodontic therapy with irreversible pulpitis or necrotic pulp after a single pretreatment dose of ketorolac, prednisolone, or placebo. Preemptive analgesia has a proven efficacy in surgical pain models (8). Because the endodontic pain model is different from the surgical pain model, an uncertainty exists in the effectiveness of preemptive anti-inflammatory drugs on endodontic pain. Several

Conclusion

Within the limitations of this study, the present study concludes that a single pretreatment dose of prednisolone has a more sustained effect in reducing postendodontic pain compared with placebo or ketorolac.

Acknowledgments

The authors thank Dr Umesh for his valuable contribution in statistical analysis.

The authors deny any conflicts of interest related to this study.

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