Effect of Fentanyl on the Rate of Anesthesia

Painful Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794533
• Other study ID #: 18050
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2013
• Last updated: February 16, 2013
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 56 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Painful Irreversible Pulpitis
• Pulpitis

Intervention

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
• 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)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Azad University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in depth of anesthesia	The measuring method of the pain is Electric pulp tester	Change from Baseline up to 17 minutes	No
Secondary	change from baseline in intensity of the pain	using visual analog scale(VAS)	Change from Baseline up to 60 minutes	No