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Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

NCT04961268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-07-19

No results posted yet for this study

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.

Conditions

  • Symptomatic Irreversible Pulpitis

Interventions

DRUG

TraMADol 50 Mg Oral Tablet

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

DRUG

Tramadol 100 MG Oral Tablet

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

DRUG

Ibuprofen 600Mg Tab

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

DRUG

ibuprofen 600 mg/acetaminophen 1000 mg

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Alfarabi Colleges

    lead OTHER

Principal Investigators

  • Amr M Elnaghy, PhD · Associate Professor of Endodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961268 on ClinicalTrials.gov