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

NCT07400471 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Post Endodontic Pain
  • Mechanical Detection Threshold
  • Mechanical Pain Threshold
  • Mechanical Pain Sensitivity

Interventions

DRUG

Pregabalin- 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.

DRUG

Duloxetine- 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.

Sponsors & Collaborators

  • Chattogram International Dental College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2027-03-30
Completion
2027-04-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400471 on ClinicalTrials.gov