Recruiting NCT07400471
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain Following Root Canal Therapy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin- Acetaminophen, Duloxetine- Acetaminophen.
- Who it may be relevant to
- Registry conditions: Post Endodontic Pain, Mechanical Detection Threshold, Mechanical Pain Threshold, Mechanical Pain Sensitivity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain.
Overview
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.
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.
Primary outcome measures
- Effects of Preemptive multimodal analgesia on post endodontic pain [Time frame: 6, 12, 24, 48, 72 hours]
Secondary outcome measures (3)
- Mechanical Detection Threshold [Time frame: baseline, 72 hours]
- Mechanical Pain Threshold [Time frame: baseline, 72 hours]
- Mechanical Pain Sensitivity [Time frame: baseline, 72 hours]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Professor. Dr. Md. Abu Saeed Ibn Harun — Chittagong
Publications
- Anibal Diogenes, Michael A. Henry. Pain Pathways and Mechanisms of the Pulpodentin Complex. Chapter 8; Seltzer and Bender's Dental Pulp. 2nd edition. Quintessence Publishing Co Inc;2012.
- Jang YE, Kim Y, Kim BS. Influence of Preoperative Mechanical Allodynia on Predicting Postoperative Pain after Root Canal Treatment: A Prospective Clinical Study. J Endod. 2021 May;47(5):770-778.e1. doi: 10.1016/j.joen.2021.01.004. Epub 2021 Jan 29. PMID 33516824
- Alelyani AA, Azar PS, Khan AA, Chrepa V, Diogenes A. Quantitative Assessment of Mechanical Allodynia and Central Sensitization in Endodontic Patients. J Endod. 2020 Dec;46(12):1841-1848. doi: 10.1016/j.joen.2020.09.006. Epub 2020 Sep 15. PMID 32941893
- Wiech K, Ploner M, Tracey I. Neurocognitive aspects of pain perception. Trends Cogn Sci. 2008 Aug;12(8):306-13. doi: 10.1016/j.tics.2008.05.005. Epub 2008 Jul 5. PMID 18606561
- Md. Abu Saeed Ibn Harun et al. The dimension and severity of orofacial pain in patients with current and chronic odontogenic pain. M Dent J 2021; 41(3): 235-244.
- Woolf CJ. Windup and central sensitization are not equivalent. Pain. 1996 Aug;66(2-3):105-8. No abstract available. PMID 8880830
- Md. Abu Saeed Ibn Harun et al. Endogenous Pain modulation of Irreversible Pulpitis and Persistent Endodontic Pain. Chattagram International Dental College Journal 2019; 2(1):9-13.
- O'Keefe EM. Pain in endodontic therapy: preliminary study. J Endod. 1976 Oct;2(10):315-9. doi: 10.1016/S0099-2399(76)80047-7. No abstract available. PMID 1068208
Identifiers
NCT: NCT07400471 · ERC-BBS/2025/0015-44/2025