RecruitingEarly Phase 1NCT07400471

The Effects of Preemptive Multimodal Analgesic on Endodontic Pain Following Root Canal Therapy.

The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.


Sponsor

Chattogram International Dental College

Enrollment

280 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Summary

A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • Patient's aged 18 years more.
  • ASA physical status I-II.
  • Patient with the complain of pain originated from teeth and surrounding structure.
  • Preoperative pain severity is moderate to severe.
  • Patient can be able to make communication about their pain.
  • Patients give consent to attain this research.
  • Patients have others concomitant chronic pain.
  • Patients who will have non-surgical endodontic treatment.
  • Patients who will have non-surgical endodontic retreatment.
  • Patients who will have surgical endodontic treatment.

Exclusion Criteria12

  • Patient would not like to attain in research.
  • Patients have any medical condition those are contra indication for study drug.
  • ASA physical status III, IV, V.
  • Patient already under treated any anti convulsent drug.
  • Patient participant in other clinical trials.
  • Lack of motivation or poor adharence to study protocols.
  • Patient with Pregnancy
  • Severe organ dysfunction
  • Patient have Hepatitis B, and other cross infection disease like (HIV)
  • Uncontrolled comorbidities that patient do not fit for endodontic treatment.
  • Severe cognitive impaired patients.
  • History of certain cancers or severe hematological issues.

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Interventions

DRUGPregabalin- Acetaminophen

Preemptive Multi modal analgesic drug: Experimental group will be divided into 2 subgroups according to use of drug. A. Pregabalin-acetaminophen. B. Duloxetine-Acetaminophen Pregabalin-acetaminophen: Before a half-hour endodontic treatment, patients in this group will receive a single dosage of 50 mg pregabalin and 500 mg acetaminophen. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.

DRUGDuloxetine- Acetaminophen

Duloxetine-Acetaminophen: Prior to a half-hour endodontic treatment, patients in this group will receive a single dosage of 500 mg of acetaminophen and 30 mg of Duloxetine. If necessary, acetaminophen dosages of 500 mg will be administered three times a day.


Locations(1)

Professor. Dr. Md. Abu Saeed Ibn Harun

Chittagong, Chattogram, Bangladesh

View Full Details on ClinicalTrials.gov

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NCT07400471