Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263289
Status:
UNKNOWN
Last Update Posted:
2005-12-08
First Post:
2005-12-07
Brief Title:
Preprocedural Fasting and Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment of Children
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
The Effect of Preprocedural Fasting on Vomiting Frequency in Children Administered Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nitrous oxide analgesia is used routinely for the dental treatment of anxious or uncooperative pediatric patients In many instances it is used alone without any supplemental oral premedication A controversy exists among pediatric dentists and pediatric dental departments regarding the need to apply pre-procedural fasting PF or other limitations on children undergoing dental treatment with nitrous oxide aloneThe purpose of this study is to investigate the association between PF and the frequency of vomiting in pediatric patients receiving dental treatment with nitrous oxide analgesia
Detailed Description:
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
Evaluation
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
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
Evaluation
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None