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
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