Dental Carie; Orthodontics Clinical Trial
Official title:
Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
| Verified date | April 2018 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.
| Status | Completed |
| Enrollment | 364 |
| Est. completion date | April 2018 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility |
Inclusion Criteria: - Patients under 18 years - Use of nitrous oxide/oxygen analgesia/anxiolysis - Any type of dental care Exclusion Criteria: - Use of midazolam - Use of general anesthesia |
| Country | Name | City | State |
|---|---|---|---|
| France | Violaine Smaïl-Faugeron | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | occurrence of vomiting | from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment |