Preprocedural Fasting and Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment of Children
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|ClinicalTrials.gov Identifier: NCT00263289|
Recruitment Status : Unknown
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : December 8, 2005
Last Update Posted : December 8, 2005
|Condition or disease||Intervention/treatment|
|Vomiting||Procedure: preprocedural fasting|
Materials and methods The experimental protocol will be submitted for approved by the Institutional Human Subjects Ethics committee of Hadassah-Hebrew University School of Dental l Medicine. Informed consent will be obtained from all parents or legal guardians of participating subjects.
Subjects All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I). Prior to one session subjects will be restricted and have a preprocedural fasting as per the following guidelines: All subjects will be without solids (including milk) for at least 4 hours prior to nitrous oxide administration and without clear liquids 2 hours before treatment. On the alternative session subjects will have no restrictions on their food or liquid intake.
A survey will be given to parents prior to treatment and information regarding the following will be gathered:
Age, previous nitrous oxide experience, history of vomiting or nausea (motion sickness, foods etc), last mea: what and when? The resident administering treatment will record the following: Duration of inhalation administration, percentage of nitrous oxide and flow rate, steady or fluctuating, occurrence of vomiting during or immediately following treatment.
Statistical analysis of data will determine the incidence of vomiting and if any significant differences between the two sessions exist.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||The Effect of Preprocedural Fasting on Vomiting Frequency in Children Administered Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment|
|Study Start Date :||January 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263289
|Hadassah Medical Organization,|
|Principal Investigator:||Ari Kupietzky, DMD MSc||Clinical Instructor, Department of Pediatric Dentistry, Hadassah School of Dental Medicine|