Effect of Sufentanil on the Rate of Anesthesia

NCT01572116 | Completed Phase 2 DMC

• 1 other identifier: IRCT201110137790N1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.

Conditions

Irreversible Pulpitis

Keywords

sufentanil; irreversible pulpitis; intra ligament injection

Outcome Measures

Primary Outcomes (1)

• depth of anesthesia

  The measuring method of the pain is Electric pulp tester

  in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment

Secondary Outcomes (1)

• intensity of the pain

  before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy

Study Arms (2)

Lidocaine with Epinephrine+ Normal saline

PLACEBO COMPARATOR

Drug: Lidocaine with Epinephrine+ Normal saline

Lidocaine with Epinephrine + sufentanil

ACTIVE COMPARATOR

Drug: Lidocaine with Epinephrine + sufentanil

Interventions

Lidocaine with Epinephrine+ Normal saline DRUG

PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline

Lidocaine with Epinephrine+ Normal saline

Lidocaine with Epinephrine + sufentanil DRUG

PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)

Also known as: Brand name:Sufenta

Lidocaine with Epinephrine + sufentanil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the age group of 18-65 years old
• healthy (ASA I, II)
• patients with first or second mandibular molars who need endodontic treatment
• vital tooth without a history of past endodontic treatment
• patients with clinical evidence of irreversible Pulpits with moderate to severe pain
• patients who signed consent form
• patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.

You may not qualify if:

• pregnant or nursing
• necrotic tooth
• patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
• Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
• patient with infectious diseases
• patient with moderate to sever periodontal disease
• those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Dental School of Azad University

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine; Sufentanil

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; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mandana Abedi Tari, Dentist

  Dental School of Azad University

  PRINCIPAL INVESTIGATOR

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: principal investigator

Study Record Dates

• First Submitted: March 3, 2012
• First Posted: April 6, 2012
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

IR (1)