CompletedPhase 2/3

Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain

Pakistan139 participantsStarted 2023-03-01

Plain-language summary

The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in participants presenting with irreversible pulpitis in their mandibular molar teeth. The main question\[s\] it aims to answer are: * Local anesthetic efficacy and . * Postoperative pain. Participants will receive premedication treatments 60 minutes prior to the local anesthesia administration. Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on Inferior alveolar nerve block efficacy and Postoperative pain.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I and ASA II individuals who are between the ages of 18 and 60 years. * Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis). * Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS= 1-10). * Mandibular permanent molars. Exclusion Criteria: * Patients who had taken painkillers or narcotics in the previous 12 hours * Patients suffering from severe pain because of traumatic occlusion. * Teeth with extensive damage, calcified canals, root resorption, and an open apex. * Previously root canal treated teeth. * Medically compromised patients (ASA-III and above) * Those with special communication needs or who do not understand Urdu or English language. * Pregnant and lactating women * Individual patients who will be driving back alone * Patients who are allergic to the prescribed medicines

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Local Anesthesia Efficacy

Timeframe: During access cavity preparation (deroofing)

Trial details

NCT IDNCT05982392

SponsorDow University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-15

Results submitted2026-04-05

View on ClinicalTrials.gov More Symptomatic Irreversible Pulpitis trials