Effect of Fentanyl on the Rate of Anesthesia

February 16, 2013 updated by: fatemeh khodaei, Islamic Azad University, Tehran

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

Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures; therefore, the investigators conducted this study to compare the local infiltration effect of epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia in maxillary molars with painful irreversible pulpitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were aged between 18 and 65 years with no systemic diseases categorized in the Class I ASA;
  • Individuals requiring urgent root canal treatment of maxillary first or second molars;
  • 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
  • No history of taking analgesics in the previous 12 h.

Exclusion Criteria:

  • Systemic conditions;
  • Allergic reactions to opioids, benzodiazepines, barbiturates;
  • Pregnancy and lactation; Contraindication of the use of epinephrine (such as unstable angina);
  • Nonvital pulp after access cavity preparation

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lidocaine with Epinephrine+ Normal saline
Drug: Lidocaine with Epinephrine+ Normal saline
local infiltration of 1.8 mL of 2% lidocaine containing 1:200,000 epinephrine along with 0.8 mL of 0.9% sterile normal saline solution
Drug: Lidocaine with Epinephrine + fentanyl
local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
Other Names:
  • Sublimaze,fentanil
Active Comparator: Lidocaine with Epinephrine + fentanyl
Drug: Lidocaine with Epinephrine+ Normal saline
local infiltration of 1.8 mL of 2% lidocaine containing 1:200,000 epinephrine along with 0.8 mL of 0.9% sterile normal saline solution
Drug: Lidocaine with Epinephrine + fentanyl
local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
Other Names:
  • Sublimaze,fentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in depth of anesthesia
Time Frame: Change from Baseline up to 17 minutes
The measuring method of the pain is Electric pulp tester
Change from Baseline up to 17 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in intensity of the pain
Time Frame: Change from Baseline up to 60 minutes
using visual analog scale(VAS)
Change from Baseline up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 16, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 16, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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