NCT01794533

Effect of Fentanyl on the Rate of Anesthesia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Islamic Azad University, Sanandaj · Academic / Other
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Painful Irreversible Pulpitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-02-20
• Last updated: 2013-02-20

Locations

1 site across 1 country: Iran