Can Pretreatment With Analgesics Reduce Postendodontic Pain?

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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: Pre treatment with NSAIDS; Procedure: No pretreatment with NSAIDS.

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Swat, Pakistan
    • Saidu College of dentistry,Swat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre treatment with NSAIDS; Experimental	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.
Active Comparator: No pre treatment with NSAIDS; No pretreatment medication was administered before endodontic treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 hours after endodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	24 hours after endodontic treatment

Collaborators and Investigators

• Sponsor: College of Physicians and Surgeons Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: postoperative pain; NSAIDS; Endodontic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: SCD-EndoPain-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No