Incident and Extent of Pulse Alteration During Administration of Various Modes of Local Anesthesia in Children During Routine Dental Treatment

Parents to children (healthy and with systemic disease ) who need local anesthesia (such as mandibular block, infiltration or C-CLAD-IL) for routine dental treatment will be asked to sign an informed consent form to participate in the study. The parents will receive explanation that the aim of the study is to evaluate the alteration of the pulse rate during delivery of different modes of local anesthetic delivery (an indirect sign for penetration of local anesthetic solution into the blood vessels). All patients will be connected, immediately before and during the entire delivery of the local anesthetic, to pulse oximeter ( pulse oximeter ,Boston, USA Nellcor N550) . The probe will be attached to the patient's finger or big toe according to patient's age. The pulse oximeter will be connected to a computer that will document continuously the 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 (crying, grimace, body movements or verbal complains-CHEOPS, attachment 1) will be documented on the computer in real time by another person that is not the treating dentist. This documentation is feasible due to a new program that was developed especially for this study. All types of local anesthesia delivery will be performed by the computerized controlled local anesthesia delivery system - Single-Tooth-Anesthesia (C-CLAD, STA, Milestone Scientific, Inc. Deerfield, IL, USA) which connected to a computer and documents continuously the amount and velocity of the local anesthetic delivered to the patient. This program was kindly provided and developed by Dr. Mark Hochman from USA, as part of the collaboration in the present study.

The local anesthesia will be performed by using Lidocaine 2% and Epinephrine 1:100,000, or Mepivacain HCl 3% without any vasoconstrictors as necessary. The use of local anesthetic without vasoconstrictor will serve as control for elevations of pulse rate which not resulted from penetration of adrenalin into the blood vessels.

When injecting mandibular block or infiltration, aspiration will be performed immediately before injecting the solution. In case a positive aspiration, the finding will be marked; the location of the needle will be changed until a negative aspiration will be received.

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 per 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.