Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

Mechanical Ventilation Clinical Trial

Official title:

Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419601
• Other study ID #: KKSK 251
• Secondary ID: ISRCTN06135415
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: June 24, 2010
• Start date: November 2006
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Description:

"Newborns (≥ 36 weeks of gestation) and young infants (≤ 60 days) with need of mechanical ventilation receive next to midazolam either remifentanyl or fentanyl for analgesia and sedation. The study medication will be started not later than 12 hours after intubation and the maximum application time is 96 hours. The opioid infusion rate is started with either 9µg/kg/h remifentanyl or 3µg/kg/h fentanyl and will be adapted according to a clinical sedation score (Hartwig- and Comfort score). The maximum infusion rate is 30µg/kg/h remifentanyl or 10µg/kg/h fentanyl.

To judge the efficacy of both opioids, we will evaluate the sedation scores every 6 hours and measure the skin conductance during a painful procedure (tracheal suctioning). Next to the adverse events we document different vital parameters like heart rate, blood pressure or oxygen saturation every 6 hours to estimate the safety of both opioids.

The midazolam plasma level will be determined immediately before termination of the opioid and midazolam infusion when the child is clinically judged to be ready for extubation. The child will be extubated as soon as it reaches a certain level in the sedation score and exhibits stable spontaneous breathing.

After extubation we will look in both treatment groups for the possible development of hyperalgesia by investigating the cutaneous flexor reflex with von Frey hairs. The trial ends for each patient 48 hours after extubation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

Inclusion Criteria:

• Ventilated term newborns and infants = 60 days

• Expected time of artificial ventilation between 12 and 96 hours

Exclusion Criteria:

• Neuromuscular diseases

• Drug abuse of the mother (exclusion criteria for newborns)

• Known hypersensitivity to Ultiva® or Fentanyl-Janssen®

• Missing informed consent of the parents

• Participation in another clinical trial during the last 4 weeks before start of this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Drug:
• Remifentanyl
Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h
• Fentanyl
start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h

Locations

Country	Name	City	State
Germany	Clinic for Paediatrics, University of Cologne Kerpener Str. 62	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the artificial ventilation after discontinuation of the opioid infusion	Extubation time point after discontinuation of the opioid infusion. Start of opioid infusion at the latest 12 h after intubation. Maximum duration of the opioid infusion 96 h.	at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion)	No
Secondary	Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants	During the opioid infusion we perform a score based evaluation every 6 hours. Start of opioid infusion at the latest 12 h after intubation. Maximum duration of the opioid infusion 96 h.	during opioid infusion	No
Secondary	Safety of a continuous application of remifentanyl		up to 30 days after extubation	Yes
Secondary	Possible withdrawal symptoms on both treatment groups after extubation		up to 48 h after extubation	Yes
Secondary	Discharge time from the PICU after discontinuation of the opioid infusion		at time of discharge from the PICU (average 2 d after start of study medication)	No