Incident and Extent of Pulse Alteration During Local Anesthesia in Children
1 other identifier
observational
300
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jan 2015
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 31, 2014
December 1, 2014
11 months
December 25, 2014
December 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pulse rate alteration (1-90 beates)
increase pulse rate above 50% of the baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped immediately.
10 minutes, during entire delivery of local anesthesia
Study Arms (6)
Mandibular block with Epinephrine
Lidocaine 2% with 1:100,000 Epinephrine
C-CLAD-IL with Epinephrine
Lidocaine 2% and 1:100,000 Epinephrine
Infiltration with Epinephrine
Lidocaine 2% and 1:100,000 Epinephrine
Mandibular block without Epinephrine
Mepivacain HCl 3% without Epinephrine
Infiltration without Epinephrine
Mepivacain 3% without Epinephrine
CCLAD-IL without Epinephrine
Mepivacain HCl 3% without Epinephrine
Interventions
Delivery of mandibular block anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
Delivery of C-CLAD-ILanesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
Delivery of infiltration anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
Delivery of mandibular block anesthesia for dental treatment with Mepivacaine 3% without Epineprine
Delivery of C-CLAD-ILanesthesia for dental treatment with Mepivacaine 3% without Epineprine
Delivery of infiltration anesthesia for dental treatment with Mepivacaine 3% without Epineprine
Eligibility Criteria
Children undergo routine dental treatment that require local anesthetic.
You may qualify if:
- All children that their parents signed the inform consent form and the children allow to put the pulse oximeter sensor on their finger/ear.
You may not qualify if:
- Children that does not allow to put the pulse oximeter sensor on their finger/ear.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel Aviv Universitylead
- Sheba Medical Centercollaborator
- Private practice, Dr. Malka Ashkenazicollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 25, 2014
First Posted
December 31, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
December 31, 2014
Record last verified: 2014-12