ChildrenPhase 2NCT02172014
Safety and Efficacy of Fentanyl Citrate in Children
A Phase 2 study testing midazolam and fentanyl citrate infusion and midazolam and normal saline infusion in people with Children, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Children
- What is being tested?
- midazolam and fentanyl citrate infusion and midazolam and normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jan 2015
- Phase
- Phase 2
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children mechanically ventilated
- age : from 2 months to 18 years
Who cannot join
- children with neurologic disease
- children with drugs which can affect the level of consciousness
- children with renal disease
- children with hypotension (systolic blood pressure < 70 + (2 x age in year) mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Fentanyl Citrate in Combination With Midazolam in Critically Ill Children With Mechanical Ventilation
Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation
Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation.
Read more
Design: Double-blind randomized controlled study
Patients: Patients age 2 months through 18 years who are admitted in Seoul National University Hospital pediatric intensive care unit, and applied with mechanical ventilation.
Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline) is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing pharmacist knows that.
Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent. The start time of study is when the continuous infusion of midazolam and blind reagent are begun. Assigned research nurse check Comfort behavior scale of the patient every hour regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours after begining. If there is any adverse effect or unexpected event, however, the study can be early terminated.
Read the detailed description
Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'.
Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.
- Conditions
- Children
- Being tested
- midazolam and fentanyl citrate infusion, midazolam and normal saline infusion
- Keywords
- Mechanical Ventilation, Sedation, Fentanyl, Midazolam, Comfort behavior scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam and fentanyl citrate infusionDrug
Also called midazolam injection, fentanyl citrate injection
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
midazolam and normal saline infusionDrug
Also called midazolam injection
comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | midazolam and fentanyl citrate infusion Receives: Drug: midazolam and fentanyl citrate infusion |
| Control | Placebo comparator | midazolam and normal saline infusion Receives: Drug: midazolam and normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between measured Comfort behavior scale and target Comfort behavior scale
Measured: from the start of fentanyl/placebo infusion to 48 hours after start of infusion
Secondary outcomes (4)
adverse effect
category of adverse effects
- hypotension
- coma
- ileus
Measured: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
renal dysfunction
estimate GFR (Schwartz equation) < 50 mL/minute/1.73m2
Measured: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
sedation failure
the case that can't reach target level of sedation, even though use of maximal infusion rate of midazolam and blind reagent.
Measured: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
mortality
in-hospital death
Measured: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionJan 2015
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 ChildrenStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Dong Park, MD, Seoul National University Hospital
- Investigators
- June Dong Park, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172014
- Sponsor's protocol ID
- MV_fentanyl
- Status last verified
- Nov 2015
- First submitted
- 23 May 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee B, Park JD, Choi YH, Han YJ, Suh DI. Efficacy and Safety of Fentanyl in Combination with Midazolam in Children on Mechanical Ventilation. J Korean Med Sci. 2019 Jan 7;34(3):e21. doi: 10.3346/jkms.2019.34.e21. eCollection 2019 Jan 21.
PubMed 30662387
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fentanyl Citrate in Combination With Midazolam in Critically Ill Children With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02172014
- Acronym / sponsor ID
- MV_fentanyl
- Conditions
- Children
- Keywords
- Mechanical Ventilation, Sedation, Fentanyl, Midazolam, Comfort behavior scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Jun 2014 (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.
Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation
Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation.
Design: Double-blind randomized controlled study
Patients: Patients age 2 months through 18 years who are admitted in Seoul National University Hospital pediatric intensive care unit, and applied with mechanical ventilation.
Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline) is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing pharmacist knows that.
Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent. The start time of study is when the continuous infusion of midazolam and blind reagent are begun. Assigned research nurse check Comfort behavior scale of the patient every hour regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours after begining. If there is any adverse effect or unexpected event, however, the study can be early terminated.
Detailed description
Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'.
Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: midazolam and fentanyl citrate infusionmidazolam and fentanyl citrate infusion |
| Control | Placebo comparator | Drug: midazolam and normal saline infusionmidazolam and normal saline infusion |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children mechanically ventilated
- age : from 2 months to 18 years
Key exclusion criteria (4 listed)
- children with neurologic disease
- children with drugs which can affect the level of consciousness
- children with renal disease
- children with hypotension (systolic blood pressure < 70 + (2 x age in year) mmHg)
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 |
|---|---|---|
| midazolam and fentanyl citrate infusionAlso: midazolam injection, fentanyl citrate injectioncomparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care | Drug | Fentanyl |
| midazolam and normal saline infusionAlso: midazolam injectioncomparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care | Drug | Control |
Primary outcome
difference between measured Comfort behavior scale and target Comfort behavior scale
Time frame: from the start of fentanyl/placebo infusion to 48 hours after start of infusion
4 secondary outcomes
adverse effect
Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
renal dysfunction
Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
sedation failure
Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
mortality
Time frame: from the start of fentanyl/placebo infusion to 48 hour after start of infusion
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 Nov 2015.
- Derived from this study: PubMed 30662387Lee B, Park JD, Choi YH, Han YJ, Suh DI. Efficacy and Safety of Fentanyl in Combination with Midazolam in Children on Mechanical Ventilation. J Korean Med Sci. 2019 Jan 7;34(3):e21. doi: 10.3346/jkms.2019.34.e21. eCollection 2019 Jan 21.
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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.
June Dong Park, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing midazolam and fentanyl citrate infusion and midazolam and normal saline infusion in people with Children, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 Nov 2015. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
difference between measured Comfort behavior scale and target Comfort behavior scale (time frame: from the start of fentanyl/placebo infusion to 48 hours after start of 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 NCT02172014, 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 Nov 2015.