Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

University of Cologne

Status and phase

Completed

Phase 3

Conditions

Mechanical Ventilation

Treatments

Drug: Remifentanyl

Drug: Fentanyl

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00419601

ISRCTN06135415 (Registry Identifier)

KKSK 251

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

Under 60 days old

Volunteers

No Healthy Volunteers

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