An Early Phase 1 interventional study of Pregabalin- Acetaminophen and Duloxetine- Acetaminophen in Post Endodontic Pain, Mechanical Detection Threshold and Mechanical Pain Threshold, sponsored by Chattogram International Dental College. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Chattogram International Dental College · Early Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with Chattogram International Dental College as lead sponsor.
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Exclusion Criteria:
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. 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.
Drug: Pregabalin- Acetaminophen · Drug: Duloxetine- Acetaminophen
Placebo: Patient in this group will receive placebo drug before half an hour of operating procedure. If necessary, acetaminophen dosages of 500 mg will be administered three times a day and noted
Drug: Pregabalin- Acetaminophen · Drug: Duloxetine- 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.
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.
Effects of Preemptive multimodal analgesia on post endodontic pain
Primary Pain during endodontic treatment and the effectiveness of intervention will be evaluated at 6, 12, 24, 48, 72, and hourly intervals after the endodontic procedure. Treatment-related anaesthetic efficacy will be assessed using the VAS (Visual Analogue Scale; numerical value 0-10). During endodontic treatment, the level of pain will decide how effective the anesthetic is. The patient will be asked to rate the analgesic effects on a VAS (Visual Analogue Scale) scale by providing a numerical number 0-10. '0" are indicated no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= sever pain.
Time frame: 6, 12, 24, 48, 72 hours
Mechanical Detection Threshold
Mechanical Detection Threshold: A standardized set of modified von Frey hairs (Opti-hair2-Set, Marstock Nervtest, Germany) that exert stresses upon bending between 0.25 and 512 mN graded by a factor of 2 (1-2 s contact time) were used to determine the mechanical detection threshold (MDT). With a rounded tip and 0.5 mm in diameter, the von Frey hairs' contact area with the skin was consistent in size and shape to prevent sharp edges that could aid in nociceptor activation. Five threshold determinations with a sequence of increasing and decreasing stimulus intensities were made using the "method of limits." The geometric mean of these five series served as the final threshold.
Time frame: baseline, 72 hours
Mechanical Pain Threshold
Mechanical Pain Threshold: A set of seven pin-prick mechanical stimulators with preset stimulus intensities (flat contact area of 0.2 mm diameter) that applied forces of 8, 16, 32, 64, 128, 256, and 512 mN were used to test the mechanical pain threshold (MPT). These stimuli were custom-made and weighted. Until the first perception of sharpness was attained, the stimulators were applied in ascending order at a pace of two seconds on, two seconds off. The geometric mean of five sequences of rising and descending stimuli served as the final threshold. The purpose of this test was to identify pinprick hypoalgesia. Before initiation of endodontic treatment, the patient has to take drug that's are supplied in enveloped.
Time frame: baseline, 72 hours
Mechanical Pain Sensitivity
Mechanical Pain Sensitivity will test using the same weighted pinprick stimuli as for mechanical pain threshold. To obtain a stimulus- response- function, these seven pinprick stimuli will apply in a balanced order, five times each, and patient will ask to give a pain rating for each stimulus on a 0-10 VAS scale ( '0' indicate no pain; 10 indicate most intense pain imaginable.
Time frame: baseline, 72 hours
Plan to share: No
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