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Incident and Extent of Pulse Alteration During Local Anesthesia in Children

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ClinicalTrials.gov Identifier: NCT02328729
Recruitment Status : Unknown
Verified December 2014 by Mickey Scheinowitz, PhD, Tel Aviv University.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
Sheba Medical Center
Private practice, Dr. Malka Ashkenazi
Information provided by (Responsible Party):
Mickey Scheinowitz, PhD, Tel Aviv University

Brief Summary:
Incident and extent of pulse alteration during administration of various modes of local anesthesia in children during routine dental treatment. Our aims are: (1) To estimate the percent of patients who receive mandibular block , C-CLAD-IL or infiltration injections and show increase in their pulse rate during the delivery of anesthesia (in spite of negative aspiration) as result of infiltration of adrenalin into their blood vessels. (2) To estimate the extent of pulse rate alteration in correlation with the velocity or volume of local anesthesia injected. (3) To examine the correlation between increase in the pulse rate and effectiveness of anesthesia. (4) To examine the correlation between the needle gauge (27 & 30) and increase in pulse rate during mandibular block injection in spite of negative aspiration. We will recruit children that undergo routine dental treatment under local anesthesia (such as mandibular block, infiltration or C-CLAD-IL). Patients will be connected, immediately before and during the entire delivery of the local anesthetic, to pulse-oximeter that will be connected to a computer and continuously monitor pulse rate and saturation during the delivery of local anesthesia. Each aberrant event which may occur during alteration of the pulse rate such as gag reflex, coughing, or pain related disruptive behavior will be documented on the computer in real time by another person that is not the treating dentist. All types of local anesthesia delivery will be performed by the computerized-controlled local anesthesia delivery system - Single-Tooth-Anesthesia which connected to a computer and documents continuously the amount and velocity of the local anesthetic delivered to the patient. All injections will be performed by using a 29 gauge needle, except when children will be treated under general anesthesia, the injection will be performed also by 27 gauge needle. In case the pulse rate will increase to 150% of the baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped immediately. The continuation of the local anesthetic delivery will be continued in different location and only after the return of the pulse to its basic rate. A total of 100 patients will receive local anesthetic containing 1:100,000 adrenalin and 50 patients without adrenaline. Three modes of local anesthesia will be evaluated: C-CLAD-IL, infiltration and mandibular block= a total of 300 patients.

Condition or disease Intervention/treatment
Tachycardia Procedure: mandibular block with Epinephrine Procedure: C-CLAD-IL with Epinephrine Procedure: Infiltration with Epinephrine Procedure: Mandibular block without Epinephrine Procedure: C-CLAD-IL without Epinephrine Procedure: nfiltration without Epinephrine

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Incident and Extent of Pulse Alteration During Administration of Various Modes of Local Anesthesia in Children During Routine Dental Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Group/Cohort Intervention/treatment
Mandibular block with Epinephrine
Lidocaine 2% with 1:100,000 Epinephrine
Procedure: mandibular block with Epinephrine
Delivery of mandibular block anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine

C-CLAD-IL with Epinephrine
Lidocaine 2% and 1:100,000 Epinephrine
Procedure: C-CLAD-IL with Epinephrine
Delivery of C-CLAD-ILanesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine

Infiltration with Epinephrine
Lidocaine 2% and 1:100,000 Epinephrine
Procedure: Infiltration with Epinephrine
Delivery of infiltration anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine

Mandibular block without Epinephrine
Mepivacain HCl 3% without Epinephrine
Procedure: Mandibular block without Epinephrine
Delivery of mandibular block anesthesia for dental treatment with Mepivacaine 3% without Epineprine

Infiltration without Epinephrine
Mepivacain 3% without Epinephrine
Procedure: nfiltration without Epinephrine
Delivery of infiltration anesthesia for dental treatment with Mepivacaine 3% without Epineprine

CCLAD-IL without Epinephrine
Mepivacain HCl 3% without Epinephrine
Procedure: C-CLAD-IL without Epinephrine
Delivery of C-CLAD-ILanesthesia for dental treatment with Mepivacaine 3% without Epineprine




Primary Outcome Measures :
  1. Pulse rate alteration (1-90 beates) [ Time Frame: 10 minutes, during entire delivery of local anesthesia ]
    increase pulse rate above 50% of the baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped immediately.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children undergo routine dental treatment that require local anesthetic.
Criteria

Inclusion Criteria:

All children that their parents signed the inform consent form and the children allow to put the pulse oximeter sensor on their finger/ear.

Exclusion Criteria:

Children that does not allow to put the pulse oximeter sensor on their finger/ear.


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): NCT02328729


Contacts
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Contact: Meir Rakocz, DDM 97235302850 meir.rakocz@sheba.health.gov.il

Sponsors and Collaborators
Tel Aviv University
Sheba Medical Center
Private practice, Dr. Malka Ashkenazi
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Responsible Party: Mickey Scheinowitz, PhD, PhD, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02328729    
Other Study ID Numbers: 9995-12
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents