Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants|
- Duration of the artificial ventilation after discontinuation of the opioid infusion [ Time Frame: at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion) ] [ Designated as safety issue: No ]Extubation time point after discontinuation of the opioid infusion. Start of opioid infusion at the latest 12 h after intubation. Maximum duration of the opioid infusion 96 h.
- Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants [ Time Frame: during opioid infusion ] [ Designated as safety issue: No ]During the opioid infusion we perform a score based evaluation every 6 hours. Start of opioid infusion at the latest 12 h after intubation. Maximum duration of the opioid infusion 96 h.
- Safety of a continuous application of remifentanyl [ Time Frame: up to 30 days after extubation ] [ Designated as safety issue: Yes ]
- Possible withdrawal symptoms on both treatment groups after extubation [ Time Frame: up to 48 h after extubation ] [ Designated as safety issue: Yes ]
- Discharge time from the PICU after discontinuation of the opioid infusion [ Time Frame: at time of discharge from the PICU (average 2 d after start of study medication) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 2
start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h
Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h
"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 9µg/kg/h remifentanyl or 3µg/kg/h fentanyl and will be adapted according to a clinical sedation score (Hartwig- and Comfort score). The maximum infusion rate is 30µg/kg/h remifentanyl or 10µg/kg/h 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.
|Clinic for Paediatrics, University of Cologne Kerpener Str. 62|
|Cologne, Germany, 50937|
|Principal Investigator:||Bernhard Roth, Prof.||Clinic for Paediatrics, University of Cologne|