Behavior of Children Related to Numbness After Dental Local Anesthesia

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00363207
First received: August 10, 2006
Last updated: May 19, 2008
Last verified: April 2007
  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: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia

Further study details as provided by Hadassah Medical Organization:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Diana Ram, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00363207     History of Changes
Other Study ID Numbers: STDI-HMO-CTIL
Study First Received: August 10, 2006
Last Updated: May 19, 2008
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:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014