Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419601
Status:
COMPLETED
Last Update Posted:
2010-06-25
First Post:
2007-01-05
Brief Title:
Rapip Study Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Prospective Randomized Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Status:
COMPLETED
Status Verified Date:
2010-05
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:
None
Brief Summary:
It shall be investigated whether ventilated neonates and infants with a remifentanyl based analgesia and sedation can be extubated faster after discontinuation of the opioid infusion compared to neonates and infants with a fentanyl based analgesia and sedation
Detailed Description:
Newborns 36 weeks of gestation and young infants 60 days with need of mechanical ventilation receive next to midazolam either remifentanyl or fentanyl for analgesia and sedation The study medication will be started not later than 12 hours after intubation and the maximum application time is 96 hours The opioid infusion rate is started with either 9µgkgh remifentanyl or 3µgkgh fentanyl and will be adapted according to a clinical sedation score Hartwig- and Comfort score The maximum infusion rate is 30µgkgh remifentanyl or 10µgkgh fentanyl
To judge the efficacy of both opioids we will evaluate the sedation scores every 6 hours and measure the skin conductance during a painful procedure tracheal suctioning Next to the adverse events we document different vital parameters like heart rate blood pressure or oxygen saturation every 6 hours to estimate the safety of both opioids
The midazolam plasma level will be determined immediately before termination of the opioid and midazolam infusion when the child is clinically judged to be ready for extubation The child will be extubated as soon as it reaches a certain level in the sedation score and exhibits stable spontaneous breathing
After extubation we will look in both treatment groups for the possible development of hyperalgesia by investigating the cutaneous flexor reflex with von Frey hairs The trial ends for each patient 48 hours after extubation
To judge the efficacy of both opioids we will evaluate the sedation scores every 6 hours and measure the skin conductance during a painful procedure tracheal suctioning Next to the adverse events we document different vital parameters like heart rate blood pressure or oxygen saturation every 6 hours to estimate the safety of both opioids
The midazolam plasma level will be determined immediately before termination of the opioid and midazolam infusion when the child is clinically judged to be ready for extubation The child will be extubated as soon as it reaches a certain level in the sedation score and exhibits stable spontaneous breathing
After extubation we will look in both treatment groups for the possible development of hyperalgesia by investigating the cutaneous flexor reflex with von Frey hairs The trial ends for each patient 48 hours after extubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| ISRCTN06135415 | REGISTRY | ISRCTN | None |