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 number | NCT00419601 |
| Secondary identifying numbers | KKSK-251 |
- 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
Scientific
Clinic for Paediatrics
University of Cologne
Kerpener Str. 62
Cologne
50937
Germany
Study information
| Study design | Randomised, controlled, double-blind, two-armed parallel group trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Remifentanil, fentanyl |
| Primary outcome measure | 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 study start date | 17/11/2006 |
| Completion date | 17/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 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
50937
Germany
Sponsor information
University of Cologne (Germany)
University/education
University/education
c/o Professor Dr. Bernhard Roth
Clinic for Paediatrics
Kerpener Str. 62
Cologne
50937
Germany
| Website | http://www.uni-koeln.de |
|---|---|
"ROR" |
https://ror.org/00rcxh774 |
Funders
Funder type
Industry
GlaxoSmithKline GmbH & Co. KG, Munich (Germany) - partially funded
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
