Effect of Fentanyl on the Rate of Anesthesia

NCT01794533 | Completed Phase 2 DMC

• 1 other identifier: 18050
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Irreversible Pulpitis

Keywords

Irreversible Pulpitis; Infiltration injection; Fentanyl; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in depth of anesthesia

  The measuring method of the pain is Electric pulp tester

  Change from Baseline up to 17 minutes

Secondary Outcomes (1)

• change from baseline in intensity of the pain

  Change from Baseline up to 60 minutes

Study Arms (2)

Lidocaine with Epinephrine+ Normal saline

PLACEBO COMPARATOR

Drug: Lidocaine with Epinephrine+ Normal saline; Drug: Lidocaine with Epinephrine + fentanyl

Lidocaine with Epinephrine + fentanyl

ACTIVE COMPARATOR

Drug: Lidocaine with Epinephrine+ Normal saline; Drug: Lidocaine with Epinephrine + fentanyl

Interventions

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; Lidocaine with Epinephrine+ Normal saline

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)

Also known as: Sublimaze,fentanil

Lidocaine with Epinephrine + fentanyl; Lidocaine with Epinephrine+ Normal saline

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Islamic Azad University

Tehran, Tehran Province, 19585-175, Iran

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine; Fentanyl

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Endodontics

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 20, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

IR (1)