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Effect of Sufentanil on the Rate of Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572116
First Posted: April 6, 2012
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mandana Abedi Tari, Islamic Azad University, Tehran
  Purpose
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 Intervention Phase
Irreversible Pulpitis Drug: Lidocaine with Epinephrine+ Normal saline Drug: Lidocaine with Epinephrine + sufentanil Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mandana Abedi Tari, Islamic Azad University, Tehran:

Primary Outcome Measures:
  • depth of anesthesia [ Time Frame: 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 [ Time Frame: 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)


Enrollment: 60
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name:Sufenta

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572116


Locations
Iran, Islamic Republic of
Dental School of Azad University
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Islamic Azad University, Tehran
Investigators
Principal Investigator: Mandana Abedi Tari, Dentist Dental School of Azad University
  More Information

Responsible Party: Mandana Abedi Tari, principal investigator, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT01572116     History of Changes
Other Study ID Numbers: IRCT201110137790N1
First Submitted: March 3, 2012
First Posted: April 6, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Mandana Abedi Tari, Islamic Azad University, Tehran:
sufentanil
irreversible pulpitis
intra ligament injection

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lidocaine
Sufentanil
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics