A randomised, single centre, double blind placebo controlled clinical trial involving 400 patients.
The inclusion criteria comprised systemically healthy patients between the ages of 18 and 35 years having mandibular molars with symptomatic irreversible pulpitis, radiographically normal periapical area and no pain on biting or percussion. The study was approved by the Institutional Review Board of Ethics Committee at the School of Dentistry, Cairo University, Egypt. Patients were recruited from the outpatient clinic of the Department of Endodontics.
The independent Centre for Evidence Based Dentistry performed sequence generation and allocation concealment. For allocation concealment, two tablets of each medication were placed in sequentially numbered, opaque, sealed containers. Participants and operators were unaware of the assigned group for the duration of the study. Post-graduate students were calibrated to act as operators and supervisors from the department of endodontics evaluated their clinical performance.
The participants received 40 mg of prednisolone or placebo tablets 30 minutes before single visit root canal treatment. Patients recorded the pain level 6, 12 and 24 hours after treatment on a 100mm visual analogue scale. All patients received a sham capsule to take if needed as a postoperative analgesic. If pain persisted an analgesic was prescribed.
The primary outcome was the incidence of postoperative pain at three points; 6, 12 and 24 hrs. The secondary outcomes were pain intensity and the incidence of analgesic consumption. The relative risk reduction (RRR) and the number needed-to-treat (NNT) and their 95% confidence intervals (CI) were used to represent the risk of pain incidence.
Of the 670 patients assessed for eligibility, 400 were included in the study. Only two patients of the 400 were lost to follow-up with 398 patients (prednisolone group = 198; control group = 200) being included in the analysis; 259 were women and 141 men. The mean age was 29.45 −/+ 3.7 years in the prednisolone group and 28.97 −/+3.61 years in the control group. There was no significant difference for mean age (P = 0.164), gender distribution P = 0.123) or tooth type (P = 0.56) between the two groups. The relative risk reduction in pain incidence was 20.31% (95% CI: 12.03%, 27.82%) at six hours, 23.39% (95% CI: 14.75%, 31.16%) at 12 hours and 28.85% (95% CI: 18.08%, 38.20%) at 24 hours. Prednisolone had significantly less post-obturation pain intensity compared to placebo at 6, 12 and 24 hours (P < 0.001). The relative risk reduction in sham-capsule intake was 54% (95% CI: 38%, 66%) and in analgesic intake was 55% (95% CI: 3%, 79%). No adverse effects were recorded. The NNT (number needed to treat) was five (95% CI: 4, 9) at six hours, five (95% CI: 4, 8) at 12 hours and four at 24 hours (95% CI: 3, 7).
Preoperative oral administration of a single dose of 40 mg prednisolone was beneficial for the control of postoperative pain up to 24hrs after single visit root canal treatment in patients with symptomatic irreversible pulpitis. The incidence of postoperative pain level and the need for postoperative analgesic intake decreased. The non-invasive route and minimal possible adverse events results in a favourable risk benefit-balance.
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Address for correspondence: Ahmed Elkhadem, Centre for Evidence-Based Dentistry, Cairo University, 11 Saraya ElManyal, Cairo, Egypt. Zip code 11553. E-mail: email@example.com
Elkhadem A, Ezzat K, Ramadan M, AbdelGhaffar S, Khamis D, Hassan A, Abdel-Mawgoud A, Mamdouh A, AbouZeid M, Amin S. The effect of preoperative oral administration of prednisolone on postoperative pain in patients with symptomatic irreversible pulpitis: a single-centre randomized controlled trial. Int Endod J 2017; doi: 10.1111/iej.12795. [Epub ahead ofprint] PubMed PMID: 28560802.
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Veitz-Keenan, A., Ferraiolo, D. Single dose oral prednisolone and post-operative endodontic pain. Evid Based Dent 19, 10–11 (2018). https://doi.org/10.1038/sj.ebd.6401285