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

Not Applicable

Completed

• Conditions: Analgesia/sedation; Signs and Symptoms; Analgesia

• Registration Number: ISRCTN06135415
• Lead Sponsor: niversity of Cologne (Germany)

Brief Summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22456770 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-03
• Study Completion: 2008-08-17
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Shortening of the artificial ventilation after discontinuation of the opioid infusion.<br>

Secondary Outcome Measures

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