Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495372
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-12-15
Brief Title:
Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults METODO METhoxyflurane in ODOntology
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Prospective Double-blind Randomized Comparative Study of the Use of Methoxyflurane vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults METODO METhoxyflurane in ODOntology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METODO
Brief Summary:
With a chronic shortage of dentists in some regions and an increase in life expectancy and living conditions the number of patients admitted to oral health emergencies is on the rise Pain is the main reason for consultation and is particularly exacerbated in the orofacial sphere Dental pain has several etiologies infectious inflammatory or traumatic accidentsBeyond the ethical aspects of acute pain management pain relief is a real objective Despite prioritization systems patients can wait a long time in an unsettled environment with tired and sometimes aggressive patients Numerous recommendations exist to improve analgesia in emergency departments but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain To meet this demand and facilitate the treatment process an alternative solution using methoxyflurane Penthrox could be considered This product mainly intended for emergency services has been approved in Europe since 2016 for the emergency relief of moderate to severe pain associated with trauma in conscious adult patients Thus it would be interesting to assess the value of methoxyflurane Penthrox in the management of pain in oral emergencies as a wait-and-see solution
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None