Condition category
Signs and Symptoms
Date applied
15/11/2006
Date assigned
03/01/2007
Last edited
04/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernhard Roth

ORCID ID

Contact details

Clinic for Paediatrics
University of Cologne
Kerpener Str. 62
Cologne
50937
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00419601

Protocol/serial number

KKSK-251

Study information

Scientific title

Acronym

RAPIP

Study hypothesis

It shall be investigated whether ventilated neonates and infants with a remifentanil 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.

Ethics approval

Ethics approval received from the Ethics Committee of the Medical Faculty of the University of Cologne on the 18 August 2006 (ref. no.: 06-053).

Study design

Randomised, controlled, double-blind, two-armed parallel group trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Analgesia/sedation

Intervention

Test group:
Permanent remifentanil infusion with a primary dose of 9 microgram/kg/h titrated to the individual need of the test person up to a maximum dose of 30 microgram/kg/h.

Comparison group:
Permanent fentanyl infusion with a primary dose of 3 microgram/kg/h titrated to the individual need of the test person up to a maximum dose of 10 microgram/kg/h.

The maximum duration of infusion of the test substance is 96 hours. Sedation may be continued if necessary using fentanyl.

Please note that as of 04/05/10 this record has been updated. The duration of this trial extended from 17/08/08 and was completed on 11/04/10. The original target number of participants was 20.

Intervention type

Drug

Phase

Not Specified

Drug names

Remifentanil, fentanyl

Primary outcome measures

Shortening of the artificial ventilation after discontinuation of the opioid infusion.

Secondary outcome measures

1. Documentation of the efficacy and safety of a remifentanil based analgesia and sedation of ventilated newborns and infants
2. Documentation of a potentially occuring tolerance to the analgesic effect of the opioids
3. Documentation of a potentially occuring hyperalgesia after discontinuation of the opioid infusion
4. Documentation of possible withdrawal symptoms on both treatment groups after extubation
5. Documentation of the discharge time from the Paediatric Intensive Care Unit (PICU) after discontinuation of the opioid infusion

Overall trial start date

17/11/2006

Overall trial end date

17/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ventilated term newborns and infants less than 60 days
2. Expected time of artificial ventilation between 12 and 96 hours

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

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

Recruitment start date

17/11/2006

Recruitment end date

17/08/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Clinic for Paediatrics
Cologne
50937
Germany

Sponsor information

Organisation

University of Cologne (Germany)

Sponsor details

c/o Professor Dr. Bernhard Roth
Clinic for Paediatrics
Kerpener Str. 62
Cologne
50937
Germany

Sponsor type

University/education

Website

http://www.uni-koeln.de

Funders

Funder type

Industry

Funder name

GlaxoSmithKline GmbH & Co. KG, Munich (Germany) - partially funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes