Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02886351
Brief Summary:
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.
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:
NCT02886351
Study Brief:
Protocol Section:
NCT02886351