Completed

Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis

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What is being tested

Lidocaine with Epinephrine+ Normal saline

+ Lidocaine with Epinephrine + fentanyl

+ Lidocaine with Epinephrine+ Normal saline

Drug
Who is being recruted

From 18 to 56 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorIslamic Azad University, Sanandaj
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

This study was planned with a randomized double-blind, parallel design clinical trial on 64 healthy patients after taking into account some inclusion and exclusion criteria. The control group were received the mixture of normal saline and 2% lidocaine with 1:200,000 epinephrine and the experimental group were received the mixture of fentanyl and 2% lidocaine with 1:200,000 epinephrine. The depth and duration of pulpal anesthesia were evaluated with an electric pulp testing in 5-minute intervals during a period of 60 minutes and the pain intensity recorded in five times, before injection, after injection, during access cavity preparation, pulpotomy and pulpectomy using visual analog scale(VAS). All data were analyzed and compared using chi-squared and Mann-Whitney tests.

NCT01794533
Principal SponsorIslamic Azad University, Sanandaj
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 56 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Hot painful teeth with irreversible pulpitis (moderate to severe spontaneous pain), with a positive response to thermal vitality tests (a long painful response to a cold test) and no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis; and
Individuals requiring urgent root canal treatment of maxillary first or second molars
No history of taking analgesics in the previous 12 h
Patients were aged between 18 and 65 years with no systemic diseases categorized in the Class I ASA
4 exclusion criteria prevent from participating
Allergic reactions to opioids, benzodiazepines, barbiturates
Nonvital pulp after access cavity preparation
Pregnancy and lactation; Contraindication of the use of epinephrine (such as unstable angina)
Systemic conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Islamic Azad University

Tehran, IranOpen Islamic Azad University in Google Maps
CompletedOne Study Center