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.

Condition	Intervention
Vomiting	Procedure: preprocedural fasting

Further study details as provided by Hadassah Medical Organization:

Expected Total Enrollment:  100

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.

Ages Eligible for Study:  4 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

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:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00263289

Israel
      Hadassah Medical Organization,, Jerusalem,  Israel

Study chairs or principal investigators

Ari Kupietzky, DMD MSc,  Principal Investigator,  Clinical Instructor, Department of Pediatric Dentistry, Hadassah School of Dental Medicine   

Study ID Numbers:  n20kup-HMO-CTIL
Last Updated:  December 8, 2005
Record first received:  December 7, 2005
ClinicalTrials.gov Identifier:  NCT00263289
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10