Behavior of Children Related to Numbness After Dental Local Anesthesia - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00363207

Purpose

In children, behavior management is critical to the success of pediatric dental procedures. Most of the studies on local anesthesia performed in children deal with the question how to avoid or minimize pain during injection. Due to the sensation of numbness children scratch the soft tissues and bite lips and tongue. In many cases, this may be kept in children's memory as a "painful experience" and may affect their behavior in the following visit. The purpose of this study is to evaluate children's reactions to the administration of local anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal infiltration), and to assess their behavior in the following visit related to each type of injection.

Condition
Anesthesia, Local Anesthesia, Dental

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	May 2007
Study Completion Date:	May 2008

Detailed Description:

Children between the ages of 4 to 7, undergoing dental treatment at the Department of Pediatric dentistry of the Hadassah School of Dental Medicine will participate in the study. All patients should be ASA Class I with no prior dental treatment who need at least two clinical sessions of similar operative procedures preceded by local anesthetic injection, one in each jaw, none of which due to emergency. Subjective and objective evaluation will be performed according to previously validated scales.

Eligibility

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

children receiving routine dental treatment at the hadassah school of dental medicine

Criteria

Inclusion Criteria:

Age: 4-7
Behavior: Frankel 3-4
No sedation (premedication)
ASA 1
No dental treatment before
Need for similar treatment in the upper and lower jaw
No emergency treatment

Exclusion Criteria:

Need of premedication
Uneven treatment in each jaw

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363207

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Hadassah School of Dental Medicine
jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Diana Ram, Dr

Hadassah Medical Organization

More Information

No publications provided

Responsible Party:	Hadassah Medical Organization ( Diana Ram )
Study ID Numbers:	STDI-HMO-CTIL
Study First Received:	August 10, 2006
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00363207 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

behavior
local anesthesia
behavior after dental local anesthesia

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009