Preemptive multimodal pain control for pain after root canal therapy

The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.

This trial will test whether taking pregabalin or duloxetine together with acetaminophen before root canal treatment reduces immediate and longer‑term post‑endodontic pain in adults.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chattogram International Dental College (Academic / other)
• Locations: 1 site (Chittagong, Chattogram)
• Trial ID: NCT07400471 on ClinicalTrials.gov

What this trial studies

The study compares preemptive multimodal analgesic regimens (pregabalin plus acetaminophen or duloxetine plus acetaminophen) against placebo given alongside standard endodontic care to adults with moderate to severe preoperative tooth pain. Participants who meet inclusion criteria will receive the assigned medication before undergoing non‑surgical or surgical endodontic procedures, with pain and sensory responses measured immediately and during follow‑up. Outcomes include immediate and chronic post‑endodontic pain, mechanical pain thresholds, and sensory testing, analyzed using chi‑square, t‑tests, and regression with Bonferroni correction for multiple comparisons. Placebo arms are included to help separate pharmacologic from psychological effects, and acetaminophen is available as rescue medication per protocol.

Who should consider this trial

Good fit: Adults aged 18 or older with ASA I–II who have moderate to severe tooth pain originating from the tooth or surrounding structures and who are scheduled for non‑surgical or surgical endodontic treatment and can provide informed consent are ideal candidates.

Not a fit: Patients who are pregnant, have severe organ dysfunction, are ASA III–V, are already taking anticonvulsant medications, or have contraindications to the study drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, the approach could reduce both immediate and persistent pain after root canal procedures and decrease reliance on rescue analgesics.

How similar studies have performed: There is some evidence that pregabalin and duloxetine can help neuropathic and postoperative pain, but their preemptive use specifically for post‑endodontic pain is relatively limited and not well established.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Chittagong, Chattogram

• Professor. Dr. Md. Abu Saeed Ibn Harun — Chittagong, Chattogram, Bangladesh (Recruiting)

Study contacts

• Study coordinator: Prof.Dr. Md. Abu Saeed Ibn Harun, MS

Conditions Post Endodontic Pain; Mechanical Detection Threshold; Mechanical Pain Threshold; Mechanical Pain Sensitivity; post endodontic pain; Root canal Therapy; Multimodal Analgesia; Dynamic sensory test