NCT00263289

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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
Last Updated

December 8, 2005

Status Verified

December 1, 2005

First QC Date

December 7, 2005

Last Update Submit

December 7, 2005

Conditions

Vomiting

Interventions

preprocedural fastingPROCEDURE

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization,

Jerusalem, Israel

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ari Kupietzky, DMD MSc

    Clinical Instructor, Department of Pediatric Dentistry, Hadassah School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 8, 2005

Study Start

January 1, 2006

Last Updated

December 8, 2005

Record last verified: 2005-12

Locations

IL(1)