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

NCT ID: NCT00419601

Last Updated: 2010-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-04-30

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.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2

Fentanyl

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h

1

Remifentanyl

Group Type: EXPERIMENTAL

Remifentanyl

Intervention Type: DRUG

Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h

Interventions

Remifentanyl

Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h

Intervention Type: DRUG

Fentanyl

start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h

Intervention Type: DRUG

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
• 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

• Maximum Eligible Age: 60 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Clinic for Paediatrics

Principal Investigators

Bernhard Roth, Prof.

Role: PRINCIPAL_INVESTIGATOR

Clinic for Paediatrics, University of Cologne

Locations

Clinic for Paediatrics, University of Cologne Kerpener Str. 62

Cologne, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 22456770 (View on PubMed)

Other Identifiers

ISRCTN06135415

Identifier Type: REGISTRY

Identifier Source: secondary_id

KKSK 251

Identifier Type: -

Identifier Source: org_study_id