CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled / 139 target
Drug / intervention
Tramadol +2 moredrug
Likely dose
Tramadol 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05982392
NCT05982392Phase 2CompletedHigh Momentum (3.5/mo)Completion was 34mo ago
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Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis

Dow University of Health Sciences·interventional·Posted Aug 8, 2023·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Tramadol, Naproxen Sodium, and 1 other intervention for Symptomatic Irreversible Pulpitis and Post Operative Pain. Completed, enrolled 139 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Irreversible Pulpitis, Post Operative Pain
CountriesPakistan
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedAug 8, 2023
Enrollment StartMar 1, 2023
Primary CompletionAug 15, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.9 years ago

Arms & Interventions

Tramadolactive_comparator

Group A will receive premedication of Oral tramadol 100mg,

Drug: Tramadol
Naproxen Sodiumactive_comparator

Group B will receive premedication of oral naproxen sodium 550mg.

Drug: Naproxen Sodium
Placeboplacebo_comparator

Group C, will be the control group, and Surbex-Z will be given to these patients.

Drug: Placebo

Interventions

Tramadoldrug

Tramadol 100mg will be given 60 minutes before start of procedure.

Naproxen Sodiumdrug

Naproxen sodium 550mg will be given 60 minutes before start of procedure.

Placebodrug

Placebo will be given 60 minutes before start of procedure.