Mechanical VentilationPhase 3NCT00419601
Rapip Study: Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
A Phase 3 study testing Remifentanyl and Fentanyl in people with Mechanical Ventilation, run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 60 days
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Remifentanyl and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ventilated term newborns and infants ≤ 60 days
- Expected time of artificial ventilation between 12 and 96 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Paediatrics, University of Cologne Kerpener Str. 62
Cologne, 50937
About this study
Official title: Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
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.
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- Remifentanyl, Fentanyl
- Keywords
- ventilated newborns (≥ 36 SSW)and infants (≤60 days), of any medical condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanylDrug
Start dose:9 µg/kg/h Maximum dose: 30 µg/kg/h
FentanylDrug
start dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Fentanyl Receives: Drug: Fentanyl |
| 1 | Experimental | Remifentanyl Receives: Drug: Remifentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion)
Secondary outcomes (4)
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.
Measured: during opioid infusion
Safety of a continuous application of remifentanyl
Measured: up to 30 days after extubation
Possible withdrawal symptoms on both treatment groups after extubation
Measured: up to 48 h after extubation
Discharge time from the PICU after discontinuation of the opioid infusion
Measured: at time of discharge from the PICU (average 2 d after start of study medication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Bernhard Roth, Prof., Principal investigator, Clinic for Paediatrics, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419601
- Sponsor's protocol ID
- KKSK 251
- Other IDs
- ISRCTN06135415
- Status last verified
- May 2010
- First submitted
- 5 Jan 2007
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Welzing L, Oberthuer A, Junghaenel S, Harnischmacher U, Stutzer H, Roth B. Remifentanil/midazolam versus fentanyl/midazolam for analgesia and sedation of mechanically ventilated neonates and young infants: a randomized controlled trial. Intensive Care Med. 2012 Jun;38(6):1017-24. doi: 10.1007/s00134-012-2532-1. Epub 2012 Mar 29.
PubMed 22456770
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized, Double-blinded Clinical Trial on Remifentanyl for Analgesia and Sedation of Ventilated Neonates and Infants
- ClinicalTrials.gov ID
- NCT00419601
- Acronym / sponsor ID
- KKSK 251
- Conditions
- Mechanical Ventilation
- Keywords
- ventilated newborns (≥ 36 SSW)and infants (≤60 days), of any medical condition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: FentanylFentanyl |
| 1 | Experimental | Drug: RemifentanylRemifentanyl |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ventilated term newborns and infants ≤ 60 days
- Expected time of artificial ventilation between 12 and 96 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanylStart dose:9 µg/kg/h Maximum dose: 30 µg/kg/h | Drug | 1 |
| Fentanylstart dose: 3 µg/kg/h Maximum dose: 10 µg/kg/h | Drug | 2 |
Primary outcome
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)
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.
4 secondary outcomes
Efficacy of a remifentanyl based analgesia and sedation of mechanically ventilated newborns and infants
Time frame: during opioid infusion
Safety of a continuous application of remifentanyl
Time frame: up to 30 days after extubation
Possible withdrawal symptoms on both treatment groups after extubation
Time frame: up to 48 h after extubation
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
- Derived from this study: PubMed 22456770Welzing L, Oberthuer A, Junghaenel S, Harnischmacher U, Stutzer H, Roth B. Remifentanil/midazolam versus fentanyl/midazolam for analgesia and sedation of mechanically ventilated neonates and young infants: a randomized controlled trial. Intensive Care Med. 2012 Jun;38(6):1017-24. doi: 10.1007/s00134-012-2532-1. Epub 2012 Mar 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Roth, Prof. principal investigator
Clinic for Paediatrics, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanyl and Fentanyl in people with Mechanical Ventilation, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2010.