Anemia, Sickle CellPhase 4NCT01482091
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
A Phase 4 study testing Fentanyl Citrate and Normal Saline in people with Anemia, Sickle Cell and Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Anemia, Sickle Cell, Pain
- What is being tested?
- Fentanyl Citrate and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sickle Cell Disease
- Ages 3 years - 21 years
Who cannot join
- Pregnancy
- Known allergy to Fentanyl
- Usage of daily home opiates
- Exclusion Criteria at presentation in ED with a painful crisis:
- Wong Baker FACES Pain Score <6
- Systolic blood pressure < 5 percentile for age
Show all 16Show fewer
- Oxygen saturation <92% on room air
- Temperature > 102°F
- Respiratory distress
- Priapism
- Isolated abdominal pain
- Isolated headache
- New neurological symptoms
- Severe rhinorrhea or epistaxis
- History of trauma
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
Read the detailed description
Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.
Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.
The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis
- Conditions
- Anemia, Sickle Cell, Pain
- Being tested
- Fentanyl Citrate, Normal Saline
- Keywords
- fentanyl, intranasal, sickle cell, vasoocclusive crisis, pain crisis, pediatrics
- Medical subject headings
- Anemia, Sickle Cell, Pain, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
Normal SalineDrug
A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
| Intranasal Fentnayl | Experimental | Not described Receives: Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score 20 Minutes After Administration of Study Drug
Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.
Measured: Baseline and 20 minutes after administration of study drug
Secondary outcomes (12)
Presence of Bradycardia
Number of participants who had bradycardia
Measured: Every 5 minutes until 30 minutes after study drug administration
Presence of Headache
Measured: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Admission Rate
Measured: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage
Length of Stay in ED
Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure
Measured: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
Total Amount of Narcotics Administered
Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure
Measured: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Time to Study Drug Administration
Measured: Time from triage to adminstration of study drug
Change in Pain Score at 10 Minutes
Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points.
Measured: Baseline and 10 minutes after administration of study drug
Change in Pain Score at 30 Minutes
Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.
To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points.
Measured: Baseline and 30 minutes after administration of study drug
Change in Pain Score
Due to confounding factors we were unable to obtain reliable data for this outcome
Measured: Baseline and immediately prior to IV insertion
Respiratory Distress
Participants who had respiratory distress within 30 min of study drug administration
Measured: Every 5 minutes until 30 minutes after study drug administration
Hypotension
Participants who had hypotension within 30 min of study drug administration
Measured: Every 5 minutes until 30 minutes after study drug administration
Hypoxia
Number of participants who had hypoxia within 30 min of study drug adminsitration
Measured: Every 5 minutes until 30 minutes after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Marc Fein, Montefiore Medical Center
- Investigators
- Daniel M Fein, MD, Principal investigator, Children's Hospital at MontefioreDaniel M Fein, MD, Study director, Children's Hospital at Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482091
- Sponsor's protocol ID
- 11-09-343
- Status last verified
- Jul 2016
- First submitted
- 22 Nov 2011
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01482091
- Acronym / sponsor ID
- 11-09-343
- Conditions
- Anemia, Sickle Cell, Pain
- Keywords
- fentanyl, intranasal, sickle cell, vasoocclusive crisis, pain crisis, pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
Detailed description
Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.
Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.
The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis
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 |
|---|---|---|
| Intranasal Saline | Placebo comparator | Drug: Normal Saline |
| Intranasal Fentnayl | Experimental | Drug: Fentanyl Citrate |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Sickle Cell Disease
- Ages 3 years - 21 years
Key exclusion criteria (16 listed)
- Pregnancy
- Known allergy to Fentanyl
- Usage of daily home opiates
- Wong Baker FACES Pain Score <6
- Systolic blood pressure < 5 percentile for age
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 CitrateA single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device | Drug | Intranasal Fentnayl |
| Normal SalineA single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device. | Drug | Intranasal Saline |
Primary outcome
Change in Pain Score 20 Minutes After Administration of Study Drug
Time frame: Baseline and 20 minutes after administration of study drug
Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.
12 secondary outcomes
Presence of Bradycardia
Time frame: Every 5 minutes until 30 minutes after study drug administration
Presence of Headache
Time frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Admission Rate
Time frame: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage
Length of Stay in ED
Time frame: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
Total Amount of Narcotics Administered
Time frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Time to Study Drug Administration
Time frame: Time from triage to adminstration of study drug
Change in Pain Score at 10 Minutes
Time frame: Baseline and 10 minutes after administration of study drug
Change in Pain Score at 30 Minutes
Time frame: Baseline and 30 minutes after administration of study drug
Change in Pain Score
Time frame: Baseline and immediately prior to IV insertion
Respiratory Distress
Time frame: Every 5 minutes until 30 minutes after study drug administration
Hypotension
Time frame: Every 5 minutes until 30 minutes after study drug administration
Hypoxia
Time frame: Every 5 minutes until 30 minutes after study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel M Fein, MD principal investigator
Children's Hospital at Montefiore
Daniel M Fein, MD study director
Children's Hospital at Montefiore
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 Citrate and Normal Saline in people with Anemia, Sickle Cell and Pain, run by Montefiore Medical Center at 1 site in United States.
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 16 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 19 Aug 2016. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Score 20 Minutes After Administration of Study Drug (time frame: Baseline and 20 minutes after administration of study drug). 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 19 Aug 2016.