PainPhase 4NCT03897452
NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
A Phase 4 study testing Fentanyl (5 microgram/ml) prediluted ampoules in people with Pain, run by Lund University at 1 site in Sweden.
Trial summary
The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl (5 microgram/ml) prediluted ampoules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2012to 31 Dec 2014
- Phase
- Phase 4
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical indication for analgesia before any of following procedures;
- insertion of peripheral IV-catheter
- insertion of arterial cannula
- insertion of chest tube
- other skin breaking procedure.
- Possibility to obtain blood samle after the procedure (indwelling line)
Show all 9Show fewer
- Infants all gestational ages.
- Postnatal age 0-28 days
- Informed written parental concent
Who cannot join
- Concurrent or previous opioid administration (72 h interval required)
- Abdominal surgery
- Major chromosomal anomaly
- Neonatal encephalopathy
- Use of muscle relaxant
- Hypothermia treatment after hypoxic-ischemic insult
- Clinical or biochemical evidence of hepatic failure
- Participation in other intervention trial
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Neonatal Intensive Care Unit, Skåne University Hospital
Lund, 221 85
About this study
Official title: NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1
The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
- Conditions
- Pain
- Being tested
- Fentanyl (5 microgram/ml) prediluted ampoules
- Keywords
- analgesia, neonates, procedural pain, pain assessment, physiological response, pharmacogenetics
- Medical subject headings
- Pain, Agnosia, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (5 microgram/ml) prediluted ampoulesDrug
Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.
Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl for procedural pain | Experimental | A dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement.
This is not an RCT with several arms. Receives: Drug: Fentanyl (5 microgram/ml) prediluted ampoules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics; fentanyl clearance
Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
Measured: 48 hours
Pharmacokinetics; fentanyl clearance
The serum concentration values will be analysed as Area under the curve, AUC
Measured: 6 hours
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)
Background activity
Measured: 6 hours
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),
Seizure activity
Measured: 6 hours
Secondary outcomes (5)
Pharmacodynamics, change in vital parameters
Change in heart rate
Measured: 6 hours
Pharmacodynamics, change in vital parameters
Change in mean arterial blood pressure
Measured: 6 hours
Pharmacodynamics, change in vital parameters
Change in near infrared spectroscopy
Measured: 6 hours
Pharmacodynamics, behavioural response
Pain assessment with the Premature Infant Pain Profile-revised (PIPP) score for procedural pain (0-21, with the highest value if strong pain in extremely preterm infants)
Measured: 6 hours
Pharmacodynamics, hormonal response
Blood levels of cortisol
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study startNov 2012
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Elisabeth Norman, Lund University
- Investigators
- Vineta Fellman, Professor, Principal investigator, Dep. of Pediatrics, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897452
- Sponsor's protocol ID
- EU-Grant 223767
- Other IDs
- 2011-000310-19
- Status last verified
- Mar 2019
- First submitted
- 13 Feb 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study. Prestudy to NeoOpioid; No Pain During Infancy by Adapting Off-patent Medicines. EU FP7:HEALTH - 2007-4.2-1
- ClinicalTrials.gov ID
- NCT03897452
- Acronym / sponsor ID
- EU-Grant 223767
- Conditions
- Pain
- Keywords
- analgesia, neonates, procedural pain, pain assessment, physiological response, pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Nov 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl for procedural pain | Experimental | Drug: Fentanyl (5 microgram/ml) prediluted ampoulesA dose of Fentanyl 5 microgram/ml, 0.5 microgram/kg (anticipated medium pain) or 2 microgram/kg (anticipated strong pain) will be given prior to a painful procedure during NICU-care. Repeated doses or complementary analgesics will be administered according to pain assessment and clinical judgement. This is not an RCT with several arms. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Clinical indication for analgesia before any of following procedures;
- Possibility to obtain blood samle after the procedure (indwelling line)
- Infants all gestational ages.
- Postnatal age 0-28 days
- Informed written parental concent
Key exclusion criteria (8 listed)
- Concurrent or previous opioid administration (72 h interval required)
- Abdominal surgery
- Major chromosomal anomaly
- Neonatal encephalopathy
- Use of muscle relaxant
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 |
|---|---|---|
| Fentanyl (5 microgram/ml) prediluted ampoulesBolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure. Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation). | Drug | Fentanyl for procedural pain |
Primary outcome
Pharmacokinetics; fentanyl clearance
Time frame: 48 hours
Serum concentration will be analysed and the clearance will be calculated with NONMEM pharmacokinetics.
Pharmacokinetics; fentanyl clearance
Time frame: 6 hours
The serum concentration values will be analysed as Area under the curve, AUC
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG)
Time frame: 6 hours
Background activity
Pharmacodynamics; Amplitude integrated electroencephalography (aEEG),
Time frame: 6 hours
Seizure activity
5 secondary outcomes
Pharmacodynamics, change in vital parameters
Time frame: 6 hours
Pharmacodynamics, change in vital parameters
Time frame: 6 hours
Pharmacodynamics, change in vital parameters
Time frame: 6 hours
Pharmacodynamics, behavioural response
Time frame: 6 hours
Pharmacodynamics, hormonal response
Time frame: 48 hours
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 1 Apr 2019.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Vineta Fellman, Professor principal investigator
Dep. of Pediatrics, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl (5 microgram/ml) prediluted ampoules in people with Pain, run by Lund University at 1 site in Sweden.
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 9 inclusion and 8 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 1 Apr 2019. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pharmacokinetics; fentanyl clearance (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2019.