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Trial record 24 of 451 for:    TRAMADOL

Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT02110966
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Daniel Chavarría Bolaños, Universidad Autonoma de San Luis Potosí

Brief Summary:

The purpose of this study is to evaluate the success of inferior alveolar nerve block, after the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine plus Tramadol in the same anesthetic technique and patients group.

Hypothesis:

Local application of mepivacaine plus tramadol increases the successful of inferior alveolar nerve block in patients with irreversible pulpitis.


Condition or disease Intervention/treatment Phase
Symptomatic Irreversible Pulpitis Drug: Mepivacaine Drug: Mepivacaine plus Tramadol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of the Combination Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial.
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mepivacaine plus Tramadol
1.3 ml of Mepivacaine 2% epinephrine 1:100000 mixed with 0.5 ml of Tramadol (50mg/ml) will be used for the anesthetic blockade in the experimental group
Drug: Mepivacaine plus Tramadol
0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.
Other Name: Tradol

Active Comparator: Mepivacaine
The control group will receive the inferior alveolar nerve block using 1.8 ml of Mepivacaine 2% epinephrine 1: 100000.
Drug: Mepivacaine
Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.
Other Name: Dentocaín




Primary Outcome Measures :
  1. success of the inferior alveolar nerve block [ Time Frame: 0-30 minutes ]
    The anesthetic blockade will be assessed by a three step examination: lip numbess, positive/negative response to cold testing and clinical discomfort during endodontic access. Inferior alveolar nerve block success will be defined as the absence of pain during any of these evaluations and if patients report pain an analogue visual scale will be used. Also, the patient will reported the level of pain in the application of the inferior alveolar nerve block using mepivacaine and mepivacaine plus tramadol and local and systemic side effects will be monitored.


Secondary Outcome Measures :
  1. Anesthetic effect duration [ Time Frame: 0-14 hours ]
    The time of the anesthetic effect will be evaluated in patients in whom anesthetic success is achieved, and also the consume of emergency and rescue post-operative analgesics. Side effects will also be monitored during this period.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects diagnosed with symptomatic irreversible pulpitis in the first and second mandibular molars.

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity to local anesthetics and Tramadol
  • Teeth with insufficient tooth structure for restoration, periodontal disease, root resorption, root fracture
  • Systemic diseases: diabetes, uncontrolled hypertension.
  • Patients taking drugs or narcotics.
  • Patients who have used analgesics in the last 8 hours.
  • Patients ingested IMAOS and tricyclic antidepressants 14 days before.
  • Patients ingested carbamazepine (anticonvulsants)
  • Patients in active treatment with ketoconazole and erythromycin.

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): NCT02110966


Locations
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Mexico
Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University
San Luis Potosi, Mexico, 78290
Sponsors and Collaborators
Daniel Chavarría Bolaños
Investigators
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Principal Investigator: Laura Rodríguez, DDS Universidad Autónoma San Luis Potosí
Study Director: Daniel Chavarria, MSc, PhD Universidad Autonoma San Luis Potosi
Study Chair: Amaury Pozos, MSc, PhD Universidad Autonoma San Luis Potosi

Publications of Results:

Other Publications:
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Responsible Party: Daniel Chavarría Bolaños, Basic Sciences Laboratory, Dentistry School, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT02110966     History of Changes
Other Study ID Numbers: CEIFE-008-014
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Daniel Chavarría Bolaños, Universidad Autonoma de San Luis Potosí:
Anaesthetic effect
Inferior alveolar nerve block
Local tramadol
Mepivacaine
Symptomatic irreversible pulpitis.
Additional relevant MeSH terms:
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Tramadol
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Epinephrine
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Anesthetics, Local