PainPhase 4NCT03682211
Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children
A Phase 4 study testing Fentanyl Citrate and Morphine sulphate in people with Pain and Sickle Cell Disease, run by University College Dublin at 1 site in Ireland.
Trial summary
Sickle cell anaemia is an inherited blood disorder which results in abnormal sickle shaped red blood cells which do not fit well through small blood vessels. These blockages prevent oxygen (in blood) from reaching different parts of the body resulting in painful crisis. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Pain, Sickle Cell Disease
- What is being tested?
- Fentanyl Citrate and Morphine sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIreland
- Study dates
- 12 Dec 2012to 14 Nov 2013
- 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 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 1 - 21 years
- Weight ≥10 kg and ≤70 kg
- Known sickle cell disease presenting with severe pain
- Written informed consent, ideally from both parents (and assent, where appropriate), obtained prior to painful crisis (for example, in Haematology clinic)
- Verbal consent (and assent, where appropriate) obtained at the time of the painful crisis in the ED
- Hospital admission required for painful crisis
Who cannot join
- Patient has received parenteral narcotic analgesic within 4 hours of ED presentation
- Oxygen saturations below 95% on initial assessment
- Altered conscious state as defined by a Glasgow Coma score less than 15
- Contraindications to fentanyl/morphine usage
- Inability to secure IV access
- Patient has participated in another clinical trial involving an Investigation Medicinal Product (IMP) within 4 weeks of dosing, or is currently enrolled in another clinical trial involving an IMP, or has been previously enrolled in this trial
- Patients who have any condition that would make him/her, in the opinion of the Investigator or Sponsor, unsuitable for the study, or who are, in the opinion of the Investigator, not likely to complete the study for any reason
- Blocked or traumatised nose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Fentanyl Versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children
Sickle cell anaemia is an inherited blood disorder which results in abnormal sickle shaped red blood cells which do not fit well through small blood vessels. These blockages prevent oxygen (in blood) from reaching different parts of the body resulting in painful crisis. This study will compare the effectiveness of two types of pain medication, one given through a vein and one squirted up the nose.
Read the detailed description
Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain.
This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05.
This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting.
- Conditions
- Pain, Sickle Cell Disease
- Being tested
- Fentanyl Citrate, Morphine sulphate
- Keywords
- Sickle cell disease, Paediatric, Pain, Analgesia, Intranasal, Fentanyl
- Medical subject headings
- Pain, Anemia, Sickle Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
Also called Fentanyl, Sublimaze
50 μg/ml fentanyl citrate (Sublimaze, Janssen Cilag, Ltd, Marketing Authorisation No. PA 0748/044/001) administered intranasally using the MAD Nasal Intranasal Mucosal Atomiser Device
Morphine sulphateDrug
Also called Morphine sulfate, Morphine
10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Active Intranasal Fentanyl | Experimental | Subjects will receive 50 μg/ml intranasal fentanyl citrate and a placebo matched to intravenous morphine (1 ml water for injection) at time 0 Receives: Drug: Fentanyl Citrate |
| Active IV Morphine | Active comparator | Subjects will receive 10 mg/ml intravenous morphine sulphate and a placebo matched to intranasal fentanyl (2 ml water) Receives: Drug: Morphine sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.
Severity of pain as measured using a validated pain score (visual analogue scale) at 10 minutes after administration of the intervention. The the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler will be used as age-appropriate pain scales for pre-verbal/early verbal children and older verbal children respectively.
Measured: 10 minutes
Secondary outcomes (2)
Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.
Severity of pain as measured using a validated pain score (visual analogue scale) at 0, 5, 15, 20, 30, 60 and 120 minutes after administration of the intervention. The the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler will be used as age-appropriate pain scales for pre-verbal/early verbal children and older verbal children respectively.
Measured: 0, 5, 15, 20, 30, 60 and 120 minutes
The proportion of participants requiring rescue opioid requirement.
The proportion of patients requiring rescue opioid analgesia.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start12 Dec 2012
- Primary completion14 Nov 2013
- Study completion14 Nov 2013
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 PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, double-blind, double-dummy active control trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- National Children's Research Centre, Our Lady's Children's Hospital, Crumlin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682211
- Sponsor's protocol ID
- SCC01
- Other IDs
- 2011-005161-20, ISRCTN67469672
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barrett MJ, Cronin J, Murphy A, McCoy S, Hayden J, an Fhaili S, Grant T, Wakai A, McMahon C, Walsh S, O'Sullivan R. Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: study protocol for a randomised controlled trial. Trials. 2012 May 30;13:74. doi: 10.1186/1745-6215-13-74.
PubMed 22647439
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl Versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children
- ClinicalTrials.gov ID
- NCT03682211
- Acronym / sponsor ID
- SCC01
- Conditions
- Pain, Sickle Cell Disease
- Keywords
- Sickle cell disease, Paediatric, Pain, Analgesia, Intranasal, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- National Children's Research Centre, Our Lady's Children's Hospital, Crumlin
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 14 Nov 2013 (actual)
- Study completion
- 14 Nov 2013 (actual)
- First posted
- 24 Sep 2018 (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.
Sickle cell anaemia is an inherited blood disorder which results in abnormal sickle shaped red blood cells which do not fit well through small blood vessels. These blockages prevent oxygen (in blood) from reaching different parts of the body resulting in painful crisis. This study will compare the effectiveness of two types of pain medication, one given through a vein and one squirted up the nose.
Detailed description
Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain.
This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05.
This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomised, double-blind, double-dummy active control trial
| Arm | Type | Receives |
|---|---|---|
| Active Intranasal Fentanyl | Experimental | Drug: Fentanyl CitrateSubjects will receive 50 μg/ml intranasal fentanyl citrate and a placebo matched to intravenous morphine (1 ml water for injection) at time 0 |
| Active IV Morphine | Active comparator | Drug: Morphine sulphateSubjects will receive 10 mg/ml intravenous morphine sulphate and a placebo matched to intranasal fentanyl (2 ml water) |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Ages 1 - 21 years
- Weight ≥10 kg and ≤70 kg
- Known sickle cell disease presenting with severe pain
- Written informed consent, ideally from both parents (and assent, where appropriate), obtained prior to painful crisis (for example, in Haematology clinic)
- Verbal consent (and assent, where appropriate) obtained at the time of the painful crisis in the ED
Key exclusion criteria (8 listed)
- Patient has received parenteral narcotic analgesic within 4 hours of ED presentation
- Oxygen saturations below 95% on initial assessment
- Altered conscious state as defined by a Glasgow Coma score less than 15
- Contraindications to fentanyl/morphine usage
- Inability to secure IV access
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 CitrateAlso: Fentanyl, Sublimaze50 μg/ml fentanyl citrate (Sublimaze, Janssen Cilag, Ltd, Marketing Authorisation No. PA 0748/044/001) administered intranasally using the MAD Nasal Intranasal Mucosal Atomiser Device | Drug | Active Intranasal Fentanyl |
| Morphine sulphateAlso: Morphine sulfate, Morphine10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously. | Drug | Active IV Morphine |
Primary outcome
Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.
Time frame: 10 minutes
Severity of pain as measured using a validated pain score (visual analogue scale) at 10 minutes after administration of the intervention. The the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler will be used as age-appropriate pain scales for pre-verbal/early verbal children and older verbal children respectively.
2 secondary outcomes
Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.
Time frame: 0, 5, 15, 20, 30, 60 and 120 minutes
The proportion of participants requiring rescue opioid requirement.
Time frame: 120 minutes
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 24 Sep 2018.
- Background: PubMed 22647439Barrett MJ, Cronin J, Murphy A, McCoy S, Hayden J, an Fhaili S, Grant T, Wakai A, McMahon C, Walsh S, O'Sullivan R. Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: study protocol for a randomised controlled trial. Trials. 2012 May 30;13:74. doi: 10.1186/1745-6215-13-74.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Morphine sulphate in people with Pain and Sickle Cell Disease, run by University College Dublin at 1 site in Ireland.
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 6 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 24 Sep 2018. 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 Ireland. 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?
Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler. (time frame: 10 minutes). 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 NCT03682211, 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 24 Sep 2018.