Completed

NCT Number: NCT01794533

Effect of Fentanyl on the Rate of Anesthesia

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.

Completed

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Key information

Conditions

Painful Irreversible Pulpitis

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Islamic Azad University

Tehran, Tehran Province, 19585-175, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine with Epinephrine+ Normal saline

Drug

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

Lidocaine with Epinephrine + fentanyl

Drug

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

Primary outcomes

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

Secondary outcomes

change from baseline in intensity of the pain

Time frame: Change from Baseline up to 60 minutes

using visual analog scale(VAS)

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Feb 20, 2013
Registry last updated: Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.