An interventional study of Pre treatment with NSAIDS and No pretreatment with NSAIDS. in Pulpitis - Irreversible, sponsored by College of Physicians and Surgeons Pakistan. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by College of Physicians and Surgeons Pakistan · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 160 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →College of Physicians and Surgeons Pakistan is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
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Inclusion Criteria:Pakistani nationals aged 20-60 years. Diagnosis of irreversible pulpitis in a vital tooth (single or multi-rooted), confirmed by a positive cold test.
No evidence of periapical abscess on radiographs. - Exclusion Criteria:Prior use of analgesics within a specified timeframe Presence of periodontal disease.
Current use of prophylactic antibiotics.
Pregnancy or lactation.
Mental disabilities.
Systemic illnesses contraindicating endodontic therapy.
Known hypersensitivity or adverse reaction to NSAIDs.
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Experimental
Procedure: Pre treatment with NSAIDS · Procedure: No pretreatment with NSAIDS.
No pretreatment medication was administered before endodontic treatment.
Procedure: Pre treatment with NSAIDS · Procedure: No pretreatment with NSAIDS.
Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.
Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.
Incidence of Postendodontic Pain
Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS
Time frame: 6 hours after endodontic treatment
Incidence of Postendodontic Pain
Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS).
Time frame: 12 hours after endodontic treatment
Incidence of Postendodontic Pain
Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS).
Time frame: 24 hours after endodontic treatment
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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College of Physicians and Surgeons Pakistan