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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794533
Enrollment
64
Registered
2013-02-20
Start date
2012-10-31
Completion date
2013-01-31
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Irreversible Pulpitis

Keywords

Irreversible Pulpitis, Infiltration injection, Fentanyl, Lidocaine

Brief 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.

Interventions

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

DRUGLidocaine 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)

Sponsors

Islamic Azad University, Sanandaj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in depth of anesthesiaChange from Baseline up to 17 minutesThe measuring method of the pain is Electric pulp tester

Secondary

MeasureTime frameDescription
change from baseline in intensity of the painChange from Baseline up to 60 minutesusing visual analog scale(VAS)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026