Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damascus University
• Treatments: Anesthetics; Lidocaine

Criteria

Inclusion Criteria:

1. Healthy children between 7-10 years.

2. With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis.

3. Normal lip, nose, eyelid, and cheek sensation.

4. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.

Exclusion Criteria:

1. Frequent bleeding form the nose (≥ 5 per month)

2. Inadequately controlled active thyroid disease of any type.

3. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.

4. History of allergy to or intolerance of lidocaine or epinephrine.