Single dose oral prednisolone and post-operative endodontic pain

Abstract

Design

A randomised, single centre, double blind placebo controlled clinical trial involving 400 patients.

Intervention

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.

Outcome measure

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.

Results

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).

Conclusions

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.

Commentary

Endodontic treatment has been for years a source of anxiety and fear due to the association with postoperative pain.¹ Post-endodontic pain can occur within a few hours or a few days after endodontic treatment² and can be attributed to combined aetiologies. Nevertheless, any kind of postoperative pain constitutes an unwanted experience for patients and clinicians as well. Therefore, whenever possible, reduction must be accomplished, especially when the pain expected results from the treatment provided by the dentist.

Postoperative endodontic pain is frequently managed by local interventions to prevent postoperative pain using oral analgesics such as nonsteroidal analgesics and acetaminophen³ or in combination with narcotics/opioids.⁴

The endodontic treatment causes acute inflammation; hence any interventions that prevent the inflammatory response should be beneficial to the patient. Steroids used in this study may be appropriate and their use is the topic of investigation in this randomised clinical trial.

This randomised clinical trial was conducted in a methodologically appropriate manner. It was a single centre, parallel design using healthy patients in need of endodontic treatment in mandibular molars with a diagnosed symptomatic irreversible pulpitis. Bias was prevented by the use of appropriate randomisation, allocation concealment and blinding.

Dropout rate was 1% only in the intervention group, the study calculated that 200 patients should be needed in each group, 400 patients were recruited, 200 for each group, only two in the intervention group were lost.

The authors calculated the absolute risk reduction and the number needed to treat. These are important measurements to understand the true benefit of one intervention compared to another. The number needed to treat in 24 hours was approximately four. That means four patients are needed to treat with the intervention in order for one to get the benefit (a number close to one is ideal). Another way to interpret what the authors reported: 28% (56 patients from 198) had relief at six hours compared to 10% (20 patients) in the control group and that improved to 43% (86 patients) at 24 hours compared to 20.5 % (41 patients) in the control group. The incidence of analgesic intake was notably reduced in the prednisolone group compared to the control group.

This study's conclusion, along with previous studies,^{5, 6} indicates that for one visit root canal treatment, the use of a single dose of prednisolone compared to placebo to reduce pain and lessen the use of analgesics is important to consider. The use/abuse of opioids and narcotics has been much talked about and so these results deserve consideration. Other studies using other interventions should also be considered as they may provide the same benefit. The results may increase the use of steroids in medically complex patients where the use of NSAIDs or acetaminophen needs to be reduced and the use of systemically administered, single-dose steroids does not pose a contraindication.