Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-15
Brief Title:
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department a Double Blind Randomized Versus Placebo Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
INVOPE
Brief Summary:
Sickle cell disease SCD is characterized by an abnormal hemoglobin the main protein in the red blood cell From the first months of life acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain In the Emergency Department ED patients presenting with a vaso-occlusive crisis VOC required a rapid evaluation and administration of pain relief therapies and hydration
this strategy is based on an intranasal IN administration of Sufentanil at the initial management of children with VOC followed by morphine intravenous IV relay as soon as possible compared to the usual care procedure with IV morphine as soon as possible
The hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved Indeed the IN administration make it easier and faster to administer
this strategy is based on an intranasal IN administration of Sufentanil at the initial management of children with VOC followed by morphine intravenous IV relay as soon as possible compared to the usual care procedure with IV morphine as soon as possible
The hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved Indeed the IN administration make it easier and faster to administer
Detailed Description:
Sufentanil is a powerful opioid analgesic used intravenously by emergency physicians for the sedation of intensive care intubated and ventilated patients It is therefore already present in the pharmacopoeia of emergencies As the duration of action of inztranasal Sufentanil is too short to completely replace the IV morphine a very promising approach would be to use it during the initial phase of the management of severe pain in children with painful sickle cell crisis while waiting for a venous access
The INVOPE trial is a phase III trial evaluating the intranasal sufentanil in sickle cell disease children with severe VOC
The INVOPE trial is a randomized controlled multicenter double blind two parallel-group in a 11 ratio placebo-controlled superiority trial comparing the analgesic efficacy of the sufentanil IN standard care IV morphine versus placebo IN IV morphine as soon as possible
Children will be randomized in two groups
Experimental group IN Sufentanil procedure with IV administration of morphine as soon as possible
Control group IN placebo IN procedure with IV administration of morphine as soon as possible
The objective of this trial is to compare a procedure consisting in IN Sufentanil followed by IV morphine when compared to IN placebo followed by IV morphine alone in children with severe vaso-occlusive crisis
The INVOPE trial is a phase III trial evaluating the intranasal sufentanil in sickle cell disease children with severe VOC
The INVOPE trial is a randomized controlled multicenter double blind two parallel-group in a 11 ratio placebo-controlled superiority trial comparing the analgesic efficacy of the sufentanil IN standard care IV morphine versus placebo IN IV morphine as soon as possible
Children will be randomized in two groups
Experimental group IN Sufentanil procedure with IV administration of morphine as soon as possible
Control group IN placebo IN procedure with IV administration of morphine as soon as possible
The objective of this trial is to compare a procedure consisting in IN Sufentanil followed by IV morphine when compared to IN placebo followed by IV morphine alone in children with severe vaso-occlusive crisis
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