Vaso-occlusive CrisisPhase 3INVOPENCT06181695
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric
A Phase 3 study testing Sufentanil in people with Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Sickle cell disease (SCD) is characterized by an abnormal hemoglobin, the main protein in the red blood cell. From the first months of life, acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Vaso-occlusive Crisis
- What is being tested?
- Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2024to 29 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- At inclusion visit:
- Sickle-cell disease = Hemoglobin SS or SC or Sß-thalassemia
- Age < 18 years old
- Weight > 10 kgs
- Registered with the social security scheme (or State Medical Aid - AME) or his/her beneficiaries
- Informed consent of the holder (s) of the exercise of parental authority
Show all 13Show fewer
- Age < 18 years old
- At randomisation visit
- Presenting to the ED with vaso-occlusive crisis: migratory bone pain, which may occur in the limbs, spine, thorax, pelvis, skull; or crisis known as such by the patient.
- Severe pain determined at triage, defined as:
- EVENDOL ≥ 10/15 in children aged 0-8 years or
- NRS-11 ≥ 7/10 in children aged 8 years to less than 18 years
- Informed consent of the holder (s) of the exercise of parental authority signed at inclusion visit
Who cannot join
- At inclusion visit
- Known cirrhosis
- End-stage renal disease requiring kidney dialysis
- Known hypersensitivity or contraindication to sufentanil or any of the excipients
- Contraindication to morphine
- Facial malformation, epistaxis, blocked or traumatised nose
Show all 31Show fewer
- Severe asthma
- Patient's or parent's refusal to participate
- Participation in another interventional trial
- Parents who do not speak French
- At randomization visit
- Known cirrhosis
- End-stage renal disease requiring kidney dialysis
- Known hypersensitivity or contraindication to sufentanil or any of the excipients
- Contraindication to morphine
- Facial malformation, epistaxis, blocked or traumatised nose
- Severe asthma
- Patient's or Parent's refusal to participate or withdrawal of parental consent
- Participation in another interventional trial
- Patient has already been randomised to the INVOPE trial during a previous VOC
- Strong opioids received <6 hours (morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine)
- Respiratory failure (tachypnea; bradypnea; paradoxical breathing; grunting; head-bobbing; nasal flaring; retractions (subcostal, suprasternal, intercostal, sternal))
- Oxygen saturations below 95% on initial assessment
- Pneumonia requiring oxygen therapy
- Hemodynamic disorders: tachycardia, hypotension
- Altered conscious state as defined by a Glasgow Coma score less than 15
- Positive urinary pregnancy test for woman of childbearing potential (postpubertal female with sexual activity)
- Nasal or sinus surgery within 6 months before randomisation
- High fever > 39°C
- Sign of intolerance of acute anaemia
- Description by the patient (or the parents) of the unusual nature of the attack
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department: a Double Blind Randomized Versus Placebo Controlled Trial
Sickle cell disease (SCD) is characterized by an abnormal hemoglobin, the main protein in the red blood cell. From the first months of life, acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain. In the Emergency Department (ED), patients presenting with a vaso-occlusive crisis (VOC) required a rapid evaluation and administration of pain relief therapies and hydration.
this strategy is based on an intranasal (IN) administration of Sufentanil at the initial management of children with VOC, followed by morphine intravenous (IV) relay as soon as possible, compared to the usual care procedure with IV morphine as soon as possible.
The hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved. Indeed, the IN administration make it easier and faster to administer.
Read the detailed description
Sufentanil is a powerful opioid analgesic used intravenously by emergency physicians for the sedation of intensive care, intubated and ventilated patients. It is therefore already present in the pharmacopoeia of emergencies. As the duration of action of inztranasal Sufentanil is too short to completely replace the IV morphine, a very promising approach would be to use it during the initial phase of the management of severe pain in children with painful sickle cell crisis while waiting for a venous access.
The INVOPE trial is a phase III trial evaluating the intranasal sufentanil in sickle cell disease children with severe VOC.
The INVOPE trial is a randomized controlled, multicenter, double blind, two parallel-group in a 1:1 ratio, placebo-controlled superiority trial comparing the analgesic efficacy of the sufentanil IN + standard care IV morphine / versus placebo IN + IV morphine as soon as possible.
Children will be randomized in two groups:
- Experimental group: IN Sufentanil procedure with IV administration of morphine as soon as possible
- Control group : IN placebo IN procedure with IV administration of morphine as soon as possible
The objective of this trial is to compare a procedure consisting in IN Sufentanil followed by IV morphine, when compared to IN placebo followed by IV morphine alone, in children with severe vaso-occlusive crisis.
- Conditions
- Vaso-occlusive Crisis
- Being tested
- Sufentanil
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Also called sufentanil IN + morphine IV
Administration of intranasal sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil IN + Morphine IV | Experimental | Intranasal Sufentanil + IV morphine: Receives: Drug: Sufentanil |
| Placebo IN + Morphine IV | Placebo comparator | Placebo of Sufentanil administered intranasally (IN) . One single administration +IV morphine similar to the experimental arm: Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children
efficacy of the analgesia at 30 minutes after IN injection, in children with SCD presenting to the pediatric ED with a severe VOC with Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10
Measured: at 30 minutes
Secondary outcomes (7)
Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN injection inclusion
Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN injection inclusion
Measured: at 60 minutes
Proportion of children with a moderate pain (EVENDOL ≤ 9/15 or NRS-11 ≤ 6/10) at 10, 20, 30, 40, 50 and 60 minutes after the IN injection
Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN spray;
Measured: EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10 at 10, 20, 40, 50 and 60 minutes
To demonstrate that {IN Sufentanil +IV morphine(as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to decrease the level of morphine consumption
Morphine consumption (mg). Assessed morphine consumption after treatment initiation, until 60 minutes
Measured: from randomisation to 60 minutes after
To demonstrate the safety of the {IN Sufentanil +IV morphine} procedure, when compared to {IN Placebo + IV morphine } procedure, that is an absence of increase rate of hemodynamic and non-hemodynamic side effects of opiace
Rates of hypotension, hypoxia, bradycardia, respiratory distress, headache, nausea, vomiting, sleepiness and itchiness until 4 hours after the IN injection
Measured: until 4 hours after the IN injection
To evaluate the safety of all children aged 0-18 years
This outcome is defined by the proportion of patients with at least one adverse events during the medical care, until 4 hours after treatment initiatio
Measured: From randomisaton to 4 hours after
To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to improve the management of a VOC episode
Rate of admission after the ED visit
Measured: after 4 hours of randomisation
To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine(as a standard of care)} procedure, is able to decrease the proportion of VOC complications
Rate of Acute chest syndrome: at hospital discharge Rate of admission in ICU, invasive ventilation, non-invasive ventilation, oxygene therapy: at hospital discharge Rate of Transfusion: at hospital discharge Rate of death: at hospital discharge
Measured: at hospital discharg, after 4 hours after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start2 May 2024 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Vaso-occlusive CrisisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille AUPIAIS, Pre, Principal investigator, Assistance Publique des Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181695
- Sponsor's protocol ID
- APHP211035
- Acronym
- INVOPE
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prise en charge de la drépanocytose chez l'enfant et l'adolescent. Haute Autorité de Santé. Accessed March 3, 2021. https://www.has-sante.fr/jcms/c_272479/fr/prise-en-charge-de-la-drepanocytose-chez-l-enfant-et-l-adolescent
Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.
PubMed 25203083Gonzalez ER, Bahal N, Hansen LA, Ware D, Bull DS, Ornato JP, Lehman ME. Intermittent injection vs patient-controlled analgesia for sickle cell crisis pain. Comparison in patients in the emergency department. Arch Intern Med. 1991 Jul;151(7):1373-8.
PubMed 2064488Dampier CD, Smith WR, Wager CG, Kim HY, Bell MC, Miller ST, Weiner DL, Minniti CP, Krishnamurti L, Ataga KI, Eckman JR, Hsu LL, McClish D, McKinlay SM, Molokie R, Osunkwo I, Smith-Whitley K, Telen MJ; Sickle Cell Disease Clinical Research Network (SCDCRN). IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies. Clin Trials. 2013 Apr;10(2):319-31. doi: 10.1177/1740774513475850.
PubMed 23539110Treadwell MJ, Bell M, Leibovich SA, Barreda F, Marsh A, Gildengorin G, Morris CR. A Quality Improvement Initiative to Improve Emergency Department Care for Pediatric Patients with Sickle Cell Disease. J Clin Outcomes Manag. 2014 Feb;21(2):62-70.
PubMed 26412961Shenoi R, Ma L, Syblik D, Yusuf S. Emergency department crowding and analgesic delay in pediatric sickle cell pain crises. Pediatr Emerg Care. 2011 Oct;27(10):911-7. doi: 10.1097/PEC.0b013e3182302871.
PubMed 21960091Kavanagh PL, Sprinz PG, Wolfgang TL, Killius K, Champigny M, Sobota A, Dorfman D, Barry K, Miner R, Moses JM. Improving the Management of Vaso-Occlusive Episodes in the Pediatric Emergency Department. Pediatrics. 2015 Oct;136(4):e1016-25. doi: 10.1542/peds.2014-3470. Epub 2015 Sep 21.
PubMed 26391933Brandow AM, Nimmer M, Simmons T, Charles Casper T, Cook LJ, Chumpitazi CE, Paul Scott J, Panepinto JA, Brousseau DC. Impact of emergency department care on outcomes of acute pain events in children with sickle cell disease. Am J Hematol. 2016 Dec;91(12):1175-1180. doi: 10.1002/ajh.24534. Epub 2016 Sep 3.
PubMed 27517842Mathias MD, McCavit TL. Timing of opioid administration as a quality indicator for pain crises in sickle cell disease. Pediatrics. 2015 Mar;135(3):475-82. doi: 10.1542/peds.2014-2874. Epub 2015 Feb 9.
PubMed 25667245Galeotti C, Courtois E, Carbajal R. How French paediatric emergency departments manage painful vaso-occlusive episodes in sickle cell disease patients. Acta Paediatr. 2014 Dec;103(12):e548-54. doi: 10.1111/apa.12773. Epub 2014 Oct 2.
PubMed 25130719Corrigan M, Wilson SS, Hampton J. Safety and efficacy of intranasally administered medications in the emergency department and prehospital settings. Am J Health Syst Pharm. 2015 Sep 15;72(18):1544-54. doi: 10.2146/ajhp140630.
PubMed 26346210Dale O. Intranasal administration of opioids/fentanyl - Physiological and pharmacological aspects. European Journal of Pain Supplements. 2010;4(3):187-190. doi:10.1016/j.eujps.2010.06.001
Dale O, Hjortkjaer R, Kharasch ED. Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand. 2002 Aug;46(7):759-70. doi: 10.1034/j.1399-6576.2002.460702.x.
PubMed 12139528Wolfe TR, Braude DA. Intranasal medication delivery for children: a brief review and update. Pediatrics. 2010 Sep;126(3):532-7. doi: 10.1542/peds.2010-0616. Epub 2010 Aug 9.
PubMed 20696726Helmers JH, Noorduin H, Van Peer A, Van Leeuwen L, Zuurmond WW. Comparison of intravenous and intranasal sufentanil absorption and sedation. Can J Anaesth. 1989 Sep;36(5):494-7. doi: 10.1007/BF03005373.
PubMed 2529048
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department: a Double Blind Randomized Versus Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06181695
- Acronym / sponsor ID
- INVOPE / APHP211035
- Conditions
- Vaso-occlusive Crisis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 26 Dec 2023 (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 disease (SCD) is characterized by an abnormal hemoglobin, the main protein in the red blood cell. From the first months of life, acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain. In the Emergency Department (ED), patients presenting with a vaso-occlusive crisis (VOC) required a rapid evaluation and administration of pain relief therapies and hydration.
this strategy is based on an intranasal (IN) administration of Sufentanil at the initial management of children with VOC, followed by morphine intravenous (IV) relay as soon as possible, compared to the usual care procedure with IV morphine as soon as possible.
The hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved. Indeed, the IN administration make it easier and faster to administer.
Detailed description
Sufentanil is a powerful opioid analgesic used intravenously by emergency physicians for the sedation of intensive care, intubated and ventilated patients. It is therefore already present in the pharmacopoeia of emergencies. As the duration of action of inztranasal Sufentanil is too short to completely replace the IV morphine, a very promising approach would be to use it during the initial phase of the management of severe pain in children with painful sickle cell crisis while waiting for a venous access.
The INVOPE trial is a phase III trial evaluating the intranasal sufentanil in sickle cell disease children with severe VOC.
The INVOPE trial is a randomized controlled, multicenter, double blind, two parallel-group in a 1:1 ratio, placebo-controlled superiority trial comparing the analgesic efficacy of the sufentanil IN + standard care IV morphine / versus placebo IN + IV morphine as soon as possible.
Children will be randomized in two groups:
- Experimental group: IN Sufentanil procedure with IV administration of morphine as soon as possible
- Control group : IN placebo IN procedure with IV administration of morphine as soon as possible
The objective of this trial is to compare a procedure consisting in IN Sufentanil followed by IV morphine, when compared to IN placebo followed by IV morphine alone, in children with severe vaso-occlusive crisis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil IN + Morphine IV | Experimental | Drug: SufentanilIntranasal Sufentanil + IV morphine: |
| Placebo IN + Morphine IV | Placebo comparator | Drug: SufentanilPlacebo of Sufentanil administered intranasally (IN) . One single administration +IV morphine similar to the experimental arm: |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Sickle-cell disease = Hemoglobin SS or SC or Sß-thalassemia
- Age < 18 years old
- Weight > 10 kgs
- Registered with the social security scheme (or State Medical Aid - AME) or his/her beneficiaries
- Informed consent of the holder (s) of the exercise of parental authority
Key exclusion criteria (31 listed)
- At inclusion visit
- At randomization visit
- Known cirrhosis
- End-stage renal disease requiring kidney dialysis
- Known hypersensitivity or contraindication to sufentanil or any of the excipients
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 |
|---|---|---|
| SufentanilAlso: sufentanil IN + morphine IVAdministration of intranasal sufentanil | Drug | Placebo IN + Morphine IV, Sufentanil IN + Morphine IV |
Primary outcome
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children
Time frame: at 30 minutes
efficacy of the analgesia at 30 minutes after IN injection, in children with SCD presenting to the pediatric ED with a severe VOC with Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10
7 secondary outcomes
Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN injection inclusion
Time frame: at 60 minutes
Proportion of children with a moderate pain (EVENDOL ≤ 9/15 or NRS-11 ≤ 6/10) at 10, 20, 30, 40, 50 and 60 minutes after the IN injection
Time frame: EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10 at 10, 20, 40, 50 and 60 minutes
To demonstrate that {IN Sufentanil +IV morphine(as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to decrease the level of morphine consumption
Time frame: from randomisation to 60 minutes after
To demonstrate the safety of the {IN Sufentanil +IV morphine} procedure, when compared to {IN Placebo + IV morphine } procedure, that is an absence of increase rate of hemodynamic and non-hemodynamic side effects of opiace
Time frame: until 4 hours after the IN injection
To evaluate the safety of all children aged 0-18 years
Time frame: From randomisaton to 4 hours after
To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to improve the management of a VOC episode
Time frame: after 4 hours of randomisation
To demonstrate that the {IN Sufentanil +IV morphine (as a standard of care)} procedure, when compared to {IN Placebo + IV morphine(as a standard of care)} procedure, is able to decrease the proportion of VOC complications
Time frame: at hospital discharg, after 4 hours after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- BackgroundPrise en charge de la drépanocytose chez l'enfant et l'adolescent. Haute Autorité de Santé. Accessed March 3, 2021. https://www.has-sante.fr/jcms/c_272479/fr/prise-en-charge-de-la-drepanocytose-chez-l-enfant-et-l-adolescent
- Background: PubMed 25203083Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.
- Background: PubMed 2064488Gonzalez ER, Bahal N, Hansen LA, Ware D, Bull DS, Ornato JP, Lehman ME. Intermittent injection vs patient-controlled analgesia for sickle cell crisis pain. Comparison in patients in the emergency department. Arch Intern Med. 1991 Jul;151(7):1373-8.
- Background: PubMed 23539110Dampier CD, Smith WR, Wager CG, Kim HY, Bell MC, Miller ST, Weiner DL, Minniti CP, Krishnamurti L, Ataga KI, Eckman JR, Hsu LL, McClish D, McKinlay SM, Molokie R, Osunkwo I, Smith-Whitley K, Telen MJ; Sickle Cell Disease Clinical Research Network (SCDCRN). IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies. Clin Trials. 2013 Apr;10(2):319-31. doi: 10.1177/1740774513475850.
- Background: PubMed 26412961Treadwell MJ, Bell M, Leibovich SA, Barreda F, Marsh A, Gildengorin G, Morris CR. A Quality Improvement Initiative to Improve Emergency Department Care for Pediatric Patients with Sickle Cell Disease. J Clin Outcomes Manag. 2014 Feb;21(2):62-70.
- Background: PubMed 21960091Shenoi R, Ma L, Syblik D, Yusuf S. Emergency department crowding and analgesic delay in pediatric sickle cell pain crises. Pediatr Emerg Care. 2011 Oct;27(10):911-7. doi: 10.1097/PEC.0b013e3182302871.
- Background: PubMed 26391933Kavanagh PL, Sprinz PG, Wolfgang TL, Killius K, Champigny M, Sobota A, Dorfman D, Barry K, Miner R, Moses JM. Improving the Management of Vaso-Occlusive Episodes in the Pediatric Emergency Department. Pediatrics. 2015 Oct;136(4):e1016-25. doi: 10.1542/peds.2014-3470. Epub 2015 Sep 21.
- Background: PubMed 27517842Brandow AM, Nimmer M, Simmons T, Charles Casper T, Cook LJ, Chumpitazi CE, Paul Scott J, Panepinto JA, Brousseau DC. Impact of emergency department care on outcomes of acute pain events in children with sickle cell disease. Am J Hematol. 2016 Dec;91(12):1175-1180. doi: 10.1002/ajh.24534. Epub 2016 Sep 3.
- Background: PubMed 25667245Mathias MD, McCavit TL. Timing of opioid administration as a quality indicator for pain crises in sickle cell disease. Pediatrics. 2015 Mar;135(3):475-82. doi: 10.1542/peds.2014-2874. Epub 2015 Feb 9.
- Background: PubMed 25130719Galeotti C, Courtois E, Carbajal R. How French paediatric emergency departments manage painful vaso-occlusive episodes in sickle cell disease patients. Acta Paediatr. 2014 Dec;103(12):e548-54. doi: 10.1111/apa.12773. Epub 2014 Oct 2.
- Background: PubMed 26346210Corrigan M, Wilson SS, Hampton J. Safety and efficacy of intranasally administered medications in the emergency department and prehospital settings. Am J Health Syst Pharm. 2015 Sep 15;72(18):1544-54. doi: 10.2146/ajhp140630.
- BackgroundDale O. Intranasal administration of opioids/fentanyl - Physiological and pharmacological aspects. European Journal of Pain Supplements. 2010;4(3):187-190. doi:10.1016/j.eujps.2010.06.001
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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.
Camille AUPIAIS, Pre principal investigator
Assistance Publique des Hopitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sufentanil in people with Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris.
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 13 inclusion and 31 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: opening soon, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille AUPIAIS, Per (01 48 02 55 55 ext. 3 42 29, camille.aupiais@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children (time frame: at 30 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 NCT06181695, which also lists 29 linked publications.
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 26 Dec 2023.