Clinical trial NCT00419601: Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Official title: Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mechanical Ventilation
Keywords: ventilated newborns (≥ 36 SSW)and infants (≤60 days)
of any medical condition
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-01-08
Enrollment: 24
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Ventilated term newborns and infants ≤ 60 days
* Expected time of artificial ventilation between 12 and 96 hours

Exclusion Criteria:

* Neuromuscular diseases
* Drug abuse of the mother (exclusion criteria for newborns)
* Known hypersensitivity to Ultiva® or Fentanyl-Janssen®
* Missing informed consent of the parents
* Participation in another clinical trial during the last 4 weeks before start of this trial

Primary outcomes:
measure: Duration of the artificial ventilation after discontinuation of the opioid infusion
timeFrame: at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion)
Secondary outcomes:
measure: Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants
timeFrame: during opioid infusion
measure: Safety of a continuous application of remifentanyl
timeFrame: up to 30 days after extubation
measure: Possible withdrawal symptoms on both treatment groups after extubation
timeFrame: up to 48 h after extubation
measure: Discharge time from the PICU after discontinuation of the opioid infusion
timeFrame: at time of discharge from the PICU (average 2 d after start of study medication)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Clinic for Paediatrics, University of Cologne Kerpener Str. 62
Study officials:
affiliation: Clinic for Paediatrics, University of Cologne
name: Bernhard Roth, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welzing L, Oberthuer A, Junghaenel S, Harnischmacher U, Stutzer H, Roth B. Remifentanil/midazolam versus fentanyl/midazolam for analgesia and sedation of mechanically ventilated neonates and young infants: a randomized controlled trial. Intensive Care Med. 2012 Jun;38(6):1017-24. doi: 10.1007/s00134-012-2532-1. Epub 2012 Mar 29.