Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464146
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-03
Brief Title:
Pain Reduction for Limb Injuries in Pediatric Emergency Departments Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pain Reduction for Limb Injuries in Pediatric Emergency Departments A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ANTAMIN
Brief Summary:
The purpose of this study is to determine if IN fentanyl 15 µgkg or IN ketamine 1 mgkg is more effective at 30 minutes than oral morphine 05 mgkg in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED
Detailed Description:
In children with moderate to severe pain due to musculoskeletal injuries the first-line analgesic therapy in pediatric emergency departments ED is oral or intravenous morphine Due to the delay or discomfort associated with establishing IV access oral forms are preferred in French ED Unfortunately oral morphine alone or with ibuprofen or paracetamol none regimen is optimal for relieving pain in children with traumatic limb injuries However the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia Intranasal administration is easy non-invasive and usually well tolerated by children In the last years drugs with analgesic and sedative properties is increasing particularly on fentanyl ketamine which can be also administered by the IN route There are currently no studies neither published nor ongoing which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine when compared to oral morphine
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506803-25 | EUDRACT_NUMBER | None | None |