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Completed

NCT Number: NCT07271654

Can Pretreatment With Analgesics Reduce Postendodontic Pain?

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saidu College of dentistry,Swat

Swat, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Pre treatment with NSAIDS

Procedure

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pretreatment with NSAIDS.

Procedure

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

Primary outcomes

  1. Incidence of Postendodontic Pain

    Time frame: 6 hours after endodontic treatment

    Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS

Secondary outcomes

  1. Incidence of Postendodontic Pain

    Time frame: 12 hours after endodontic treatment

    Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS).

  2. Incidence of Postendodontic Pain

    Time frame: 24 hours after endodontic treatment

    Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS).

Sponsors and collaborators

Lead sponsor

College of Physicians and Surgeons Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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