NCT07271654

Can Pretreatment With Analgesics Reduce Postendodontic Pain?

Can Pretreatment With Analgesics Reduce Postendodontic Pain? A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: College of Physicians and Surgeons Pakistan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial investigated whether a single dose of diclofenac sodium taken before a root canal procedure can reduce pain in the hours following the treatment. 160 patients with tooth pain from irreversible pulpitis were divided into two groups. One group received 100mg of diclofenac sodium 30 minutes before their procedure, while the other group received no pretreatment. Pain levels were measured at 6, 12, and 24 hours after the procedure. The study found that patients who took diclofenac before treatment were significantly more likely to be pain-free at 6 and 12 hours after the procedure compared to those who did not.

Detailed description

This was a parallel-arm, randomized controlled trial conducted in the Department of Operative Dentistry, Saidu College of Dentistry. A total of 160 patients aged 20-60 years with a diagnosis of irreversible pulpitis in vital teeth were enrolled via consecutive sampling. Participants were randomized using a computer-generated sequence with allocation concealment via sealed opaque envelopes. The experimental group (n=80) received a single oral dose of 100 mg diclofenac sodium 30 minutes prior to endodontic treatment. The control group (n=80) received no pretreatment medication. All endodontic treatments were performed by experienced operators using a standardized protocol. The primary outcome was postendodontic pain intensity, assessed using a Visual Analogue Scale (VAS) and categorized as none, mild, moderate, or severe. Pain levels were recorded via structured telephone interviews at 6, 12, and 24 hours post-treatment. Statistical analysis was performed using R software, with group comparisons made using the chi-square test.

Conditions

• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Pre treatment with NSAIDS	Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.
PROCEDURE	No pretreatment with NSAIDS.	Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: Pakistan