Effect of Sufentanil on the Rate of Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mandana Abedi Tari, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier:
NCT01572116
First received: March 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mandana Abedi Tari, principal investigator, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT01572116     History of Changes
Other Study ID Numbers: IRCT201110137790N1
Study First Received: March 3, 2012
Last Updated: April 4, 2012
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Stomatognathic Diseases
Tooth Diseases
Epinephrine
Epinephryl borate
Lidocaine
Racepinephrine
Sufentanil
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics

ClinicalTrials.gov processed this record on October 22, 2014