- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02886351
High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children
August 31, 2016 updated by: MOSTAFA.SOMRI, Bnai Zion Medical Center
The use of nitrous oxide as a sedative agent is very common in pediatric dentistry.
In concentrations up to 50% it is considered as mild sedation and it is very safe.
Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia.
Higher concentration was not conducted in Pediatry densitery.
The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.
Study Overview
Detailed Description
Nitrous oxide/oxygen in varying concentrations has been successfully used for many years to provide sedation and analgesia for a variety of painful procedures in children.
The use of nitrous oxide as a sedative agent is very common in pediatric dentistry.
In concentrations up to 50% it is considered as mild sedation and it is very safe.
It is usually used for mild or moderate anxiety state because it is not so potent in concentrations up to 50 %.
Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia.
Nitrous oxide 50% is the most common concentration in use but the results of the sedation does not always provide a satisfactory cooperation, higher concentration was not conducted in Pediatry densitery.
The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mostafa Somri, M.D.
- Phone Number: # 972-4-8359304
- Email: mostafa.somri@b-zion.org.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children evaluated by a senior pediatric dentist and require a wide treatment of caries, with a high score of anxiety unable to accept dental treatment with nitrous oxide /oxide of 50% in combined with behavioral management in the pediatric dental clinic.
Exclusion criteria:
- Children with high potential risk of sedation, snoring, stridor, sleep apnea, maxillofacial malformation, history of airway difficulty, gastro esophageal reflux, reactive airway disease or acute runny nose, cardiac disease, altered mental status, inadequate fasting time.
- Parental refusal for conscious sedation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nitrous oxide
Administration of high concentration of nitrous oxygen in pediatric dentistry
|
Nitrous Oxide at 60%-70% concentration administrated by mask, to achieve cooperation in Pediatric dentisry
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Achieving cooperation in Pediatric dentistry numerical scale
Time Frame: less than 60 minutes
|
less than 60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
August 28, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 1, 2016
Study Record Updates
Last Update Posted (Estimate)
September 1, 2016
Last Update Submitted That Met QC Criteria
August 31, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BnaiZionMC-16-MS-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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