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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00419601
First received: January 5, 2007
Last updated: June 24, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Mechanical Ventilation
Drug: Remifentanyl
Drug: Fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Duration of the artificial ventilation after discontinuation of the opioid infusion [ Time Frame: at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion) ] [ Designated as safety issue: No ]
    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 [ Time Frame: during opioid infusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 30 days after extubation ] [ Designated as safety issue: Yes ]
  • Possible withdrawal symptoms on both treatment groups after extubation [ Time Frame: up to 48 h after extubation ] [ Designated as safety issue: Yes ]
  • Discharge time from the PICU after discontinuation of the opioid infusion [ Time Frame: at time of discharge from the PICU (average 2 d after start of study medication) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419601

Locations
Germany
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
  More Information

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Bernhard Roth, Clinic for Paediatrics
ClinicalTrials.gov Identifier: NCT00419601     History of Changes
Other Study ID Numbers: KKSK 251, ISRCTN06135415
Study First Received: January 5, 2007
Last Updated: June 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
ventilated newborns (≥ 36 SSW)and infants (≤60 days)
of any medical condition

Additional relevant MeSH terms:
Fentanyl
Remifentanil
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 23, 2014