Incident and Extent of Pulse Alteration During Local Anesthesia in Children

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.

Conditions

• Tachycardia

Interventions

PROCEDURE

mandibular block with Epinephrine

Delivery of mandibular block anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine

PROCEDURE

C-CLAD-IL with Epinephrine

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

PROCEDURE

Infiltration with Epinephrine

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

PROCEDURE

Mandibular block without Epinephrine

Delivery of mandibular block anesthesia for dental treatment with Mepivacaine 3% without Epineprine

PROCEDURE

C-CLAD-IL without Epinephrine

Delivery of C-CLAD-ILanesthesia for dental treatment with Mepivacaine 3% without Epineprine

PROCEDURE

nfiltration without Epinephrine

Delivery of infiltration anesthesia for dental treatment with Mepivacaine 3% without Epineprine

Sponsors & Collaborators

• Sheba Medical Center

  collaborator OTHER_GOV

• Private practice, Dr. Malka Ashkenazi

  collaborator UNKNOWN

• Tel Aviv University

  lead OTHER

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2015-12-31

Completion

2016-01-31