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Completed

NCT Number: NCT04593160

Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Egypt

About this study

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
  • Patients with moderato to severe spontaneous pain
  • Mandibular molars
  • Patients with the ability to understand and use the pain scale
  • Patients accepting enrollment in the study

Exclusion criteria

  • Patients allergic to any medication or material to be used in the study
  • Pregnant and lactating females
  • Patients taking medications affecting pain perception in the last 12 hours
  • Patients having more than one symptomatic molar in the same quadrant
  • Patients with contributory medical history (ASA > II)

Treatment and study plan

Diclofenac potassium- acetaminophen combination

Drug

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Diclofenac Potassium

Drug

Preoperative single dose of diclofenac potassium(50mg)

Placebo

Drug

Preoperative single dose of placebo

Primary outcomes

  1. Anesthetic success of inferior alveolar nerve block

    Time frame: During the treatment

    Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.

Secondary outcomes

  1. Postoperative pain at 6 hours

    Time frame: 6 hours

    Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  2. Postoperative pain at 12 hours

    Time frame: 12 hours

    Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  3. Postoperative pain at 24 hours

    Time frame: 24 hours

    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  4. Postoperative pain at 48 hours

    Time frame: 48 hours

    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  5. Postoperative pain at 72 hours

    Time frame: 72 hours

    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  6. Postoperative pain at 7 days

    Time frame: 7 days

    represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Sep 23, 2026

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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