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NCT00263289 Clinical Trial

Preprocedural Fasting and Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment of Children

Vomiting Clinical Trial

Official title:
The Effect of Preprocedural Fasting on Vomiting Frequency in Children Administered Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00263289
Other study ID # n20kup-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 7, 2005
Last updated December 7, 2005
Start date January 2006

Study information
Verified date December 2005
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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 alone.The 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Procedure:
• preprocedural fasting

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem,

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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