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

Sponsor

University of Cologne (Other)

Overall Status

Completed

CT.gov ID

NCT00419601

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation	Drug: Remifentanyl Drug: Fentanyl	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Fentanyl	Drug: Fentanyl start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h
Experimental: 1 Remifentanyl	Drug: Remifentanyl Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h

Arm

Intervention/Treatment

Active Comparator: 2

Fentanyl

Drug: Fentanyl

start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h

Experimental: 1

Remifentanyl

Drug: Remifentanyl

Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h

Outcome Measures

Primary Outcome Measures

Duration of the artificial ventilation after discontinuation of the opioid infusion [at time of extubation (expected to be within 48 hours following 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.

Secondary Outcome Measures

Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants [during opioid infusion]
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.
Safety of a continuous application of remifentanyl [up to 30 days after extubation]
Possible withdrawal symptoms on both treatment groups after extubation [up to 48 h after extubation]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Paediatrics, University of Cologne Kerpener Str. 62	Cologne		Germany	50937

Sponsors and Collaborators

University of Cologne
GlaxoSmithKline

Investigators

Principal Investigator: Bernhard Roth, Prof., Clinic for Paediatrics, University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00419601

Other Study ID Numbers:

KKSK 251
ISRCTN06135415

First Posted:

Jan 8, 2007

Last Update Posted:

Jun 25, 2010

Last Verified:

May 1, 2010

Keywords provided by , ,

ventilated newborns (≥ 36 SSW)and infants (≤60 days)

of any medical condition

Additional relevant MeSH terms:

Fentanyl

Remifentanil

Study Results

No Results Posted as of Jun 25, 2010