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

NCT00419601 | Completed Phase 3

• 2 other identifiers: KKSK 251ISRCTN06135415
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

ventilated newborns (≥ 36 SSW)and infants (≤60 days); of any medical condition

Outcome Measures

Primary Outcomes (1)

• Duration of the artificial ventilation after discontinuation of the opioid infusion

  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.

  at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion)

Secondary Outcomes (4)

• Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants

  during opioid infusion

• Safety of a continuous application of remifentanyl

  up to 30 days after extubation

• Possible withdrawal symptoms on both treatment groups after extubation

  up to 48 h after extubation

• Discharge time from the PICU after discontinuation of the opioid infusion

  at time of discharge from the PICU (average 2 d after start of study medication)

Study Arms (2)

2

ACTIVE COMPARATOR

Fentanyl

Drug: Fentanyl

1

EXPERIMENTAL

Remifentanyl

Drug: Remifentanyl

Interventions

Remifentanyl DRUG

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

1

Fentanyl DRUG

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

2

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Clinic for Paediatrics, University of Cologne Kerpener Str. 62

Cologne, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 22456770 DERIVED

MeSH Terms

Interventions

Remifentanil; Fentanyl

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bernhard Roth, Prof.

  Clinic for Paediatrics, University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 25, 2010

Record last verified: 2010-05

Locations

DE (1)