Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children
Status:
Completed
Trial end date:
2017-06-15
Target enrollment:
Participant gender:
Summary
68 healthy children from the Department of Pediatric Dentistry at Damascus University who
require treatment for their primary maxillary second molars will be randomly assigned into
one of two groups: experimental or control groups. In the experimental group, a lidocaine
hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper
second molar before the commencement of treatment.
To assess the efficacy of this kind of anesthesia, a specific scale will be used by an
external observer after capturing some video files of the performed treatment.
To assess the safety of this procedure, vital signs will be recorded before and after
treatment.
Acceptance of the nasal spray will be recorded based on the child's behavior before and after
treatment using Frankl scale.
If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be
used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2%
with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral
lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and
acceptance will be assessed in the same manner to what is performed in the experimental
group.