Effect of Sufentanil on the Rate of Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Drug: Lidocaine with Epinephrine+ Normal saline
* Drug: Lidocaine with Epinephrine + sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lidocaine with Epinephrine+ Normal saline<br> | Drug: Lidocaine with Epinephrine+ Normal saline<br>* PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline<br>|
| Active Comparator: Lidocaine with Epinephrine + sufentanil<br> | Drug: Lidocaine with Epinephrine + sufentanil<br>* PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)<br>* Other names: Brand name:Sufenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of the pain | The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sufentanil, irreversible pulpitis, intra ligament injection