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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00263289 |
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 |
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Vomiting |
Procedure: preprocedural fasting |
Study Type: | Observational |
Study Design: | Cross-Sectional, Convenience Sample, Prospective Study |
Official Title: | The Effect of Preprocedural Fasting on Vomiting Frequency in Children Administered Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment |
Estimated Enrollment: | 100 |
Study Start Date: | January 2006 |
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 to 17 Years |
Genders Eligible for Study: | Both |
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:
-
Israel | |
Hadassah Medical Organization, | |
Jerusalem,, Israel |
Principal Investigator: | Ari Kupietzky, DMD MSc | Clinical Instructor, Department of Pediatric Dentistry, Hadassah School of Dental Medicine |
Study ID Numbers: | n20kup-HMO-CTIL |
Study First Received: | December 7, 2005 |
Last Updated: | December 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00263289 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nitrous Oxide |
Anesthetics, Inhalation Anesthetics, General Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |