Effect of Sufentanil on the Rate of Anesthesia

Sponsor

Islamic Azad University, Tehran (Other)

Overall Status

Completed

CT.gov ID

NCT01572116

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irreversible Pulpitis	Drug: Lidocaine with Epinephrine+ Normal saline Drug: Lidocaine with Epinephrine + sufentanil	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Lidocaine with Epinephrine+ Normal saline	Drug: Lidocaine with Epinephrine+ Normal saline PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
Active Comparator: Lidocaine with Epinephrine + sufentanil	Drug: Lidocaine with Epinephrine + sufentanil PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg) Other Names: Brand name:Sufenta

Arm

Intervention/Treatment

Placebo Comparator: Lidocaine with Epinephrine+ Normal saline

Drug: Lidocaine with Epinephrine+ Normal saline

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

Active Comparator: Lidocaine with Epinephrine + sufentanil

Drug: Lidocaine with Epinephrine + sufentanil

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

Other Names:

Brand name:Sufenta

Outcome Measures

Primary Outcome Measures

depth of anesthesia [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]
The measuring method of the pain is Electric pulp tester

Secondary Outcome Measures

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]
The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.