CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
TraMADol 50 Mg Oral Tablet +4 moredrug
Likely dose
TraMADol 50 Mg Oral Tabletfrom 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/NCT04961268
NCT04961268N/ACompleted

Effect of Preoperative Oral Tramadol on the Anaesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind, Controlled Study

Alfarabi Colleges·interventional·Posted Jul 14, 2021·Updated Jul 19, 2021

In Brief

A clinical study evaluating TraMADol 50 Mg Oral Tablet, Tramadol 100 MG Oral Tablet, and 3 other interventions for Symptomatic Irreversible Pulpitis. Completed, enrolled 250 participants across 1 site.

Detailed Summary

Aim: The purpose of this prospective, randomized, double-blind, controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methodology: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The data were analysed using chi-square χ2 and Kruskal-Wallis tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 14, 2021
Enrollment StartJun 1, 2020
Primary CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.0 years ago

Interventions

TraMADol 50 Mg Oral Tabletdrug

The patients were randomly given the medication by mouth 60 min before administering IANB.

Tramadol 100 MG Oral Tabletdrug

The patients were randomly given the medication by mouth 60 min before administering IANB.

Ibuprofen 600Mg Tabdrug

The patients were randomly given the medication by mouth 60 min before administering IANB.

ibuprofen 600 mg/acetaminophen 1000 mgdrug

The patients were randomly given the medication by mouth 60 min before administering IANB.

Placebodrug

The patients were randomly given the medication by mouth 60 min before administering IANB.