Prospective, randomised, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants

ISRCTN	ISRCTN06135415
DOI	https://doi.org/10.1186/ISRCTN06135415
ClinicalTrials.gov (NCT)	NCT00419601
Protocol serial number	KKSK-251
Sponsor	University of Cologne (Germany)
Funder	GlaxoSmithKline GmbH & Co. KG, Munich (Germany) - partially funded

Submission date: 15/11/2006
Registration date: 03/01/2007
Last edited: 10/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bernhard Roth
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised, controlled, double-blind, two-armed parallel group trial.
Secondary study design	Randomised controlled trial
Scientific title	Prospective, randomised, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants
Study acronym	RAPIP
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Remifentanil, fentanyl
Primary outcome measure(s)	Shortening of the artificial ventilation after discontinuation of the opioid infusion.
Key secondary outcome measure(s)	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
Completion date	17/08/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	24
Key inclusion criteria	1. Ventilated term newborns and infants less than 60 days 2. Expected time of artificial ventilation between 12 and 96 hours
Key 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
Date of first enrolment	17/11/2006
Date of final enrolment	17/08/2008

Locations

Countries of recruitment

Germany

Study participating centre

Clinic for Paediatrics

Cologne
50937
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012	10/04/2019	Yes	No

Editorial Notes

10/04/2019: Publication reference added.