vaso-occlusive crisis for patients with sickle cell disease MedDRA version: 20.0 Level: LLT Classification code 10040644 Term: Sickle cell disease System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Emend 125 mg - 80 mg
Pharmaceutical Form: Capsule
Trade Name: Emend 125 mg powder
Pharmaceutical Form: Capsule
Sponsors
Centre Hospitalier Intercommunal de Créteil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Child between 6 years (age of possible use of the self-controlled Morphine pump) and 17 years (=6 years and =17 years) - Any genotype of major sickle cell syndrome (SS, SßThal, SC, SDpunjab) - Admission to pediatric emergencies for a CVO, excluding an acute splenic sequestration crisis; living at home for less than 48 hours - Requiring analgesic treatment with Morphine (Pain score = 7/10 on the scale of the faces or = 10/15 on the EVENDOL scale, according to the PEDIADOL recommendations) - Informed consent signed by parents - Affiliation to the French social security Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Children in the regular transfusion program and children who have received a hematopoietic stem cell transplant - Child hospitalized at least 5 times for CVO in the 12 months preceding the inclusion (psychic problems making difficult the evaluation of the pain) - Child who has already been included in the study during a previous CVO (each child participates in the study only once) - CVO evolving for more than 48 hours before admission to emergency - Seizure of acute splenic sequestration at admission - Children with any other pathology resulting from a painful phenotype - Child with major problems or other problems preventing the self-controlled administration of Morphine - Pregnancy - Severe hepatic or renal insufficiency - Patient with current treatment: pimozide, terfenadine, astemizole, cisapride. ciclosporin, tacrolimus, sirolimus, everolimus, alfentanil, alkaloids derived from ergot of rye, fentanyl and quinidine - Hypersensitivity to the active substance or to any of the excipients of Emend (including rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency.) - Ongoing participation in an interventional research RIPH1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate whether aprepitant administered on admission for VOC reduces the cumulative dose of morphine during hospitalization, compared to the control group.;Secondary Objective: 1 / To evaluate the effectiveness of aprepitant, in comparison with a usual care 2 / To evaluate the effectiveness of aprepitant, on the improvement of the clinical parameters during hospitalization (body temperature, respiratory rate, heart rate, air saturation in O2) 3 / Evaluate the effectiveness of aprepitant on the improvement of the H48 biological parameters of admission (leukocyte count, neutrophils, platelets, CRP, markers of hemolysis (hemoglobin, reticulocytes, bilirubin, transaminases, LDH) 4 / To evaluate the efficacy of aprepitant in reducing plasma levels of substance P during the first 48 hours of the child's VOC (H0 and H48) ;Primary end point(s): Cumulative dose of morphine (in mg / kg) during hospitalization;Timepoint(s) of evaluation of this end point: During all hospitalization time | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison in the 2 groups of: • Cumulative dose of morphine at H24, H48, H72 and every 24h until discharge (mg / kg) • Duration of hospitalization (in days) • Number of transfusion episodes • Need to add analgesic treatment (MEOPA, NEFOPAM) • Occurrence of Acute Thoracic Syndrome after admission • Readmission within 15 days of release (rebound effect) • STAI-A anxiety score (state anxiety) at admission, at H72 and the day of discharge from hospital for children ages 11 to 17 • STAI-B Anxiety Score (trait anxiety) on day of discharge from hospital and 1 month after admission for children aged 11 to 17 • R-CMAS anxiety score (trait anxiety) at admission, at H72, the day of discharge from hospital and at 1 month of admission • Pain score measured by Faces Scale-Revised (FPS) every day from admission to discharge from hospital • Maximum score of pain measured by the EVENDOL scale (range of hetero-evaluation between 1 and 15) every day from admission to discharge from hospital • Occurrence of vomiting • Occurrence of pruritus • Maximum body temperature every day from admission to discharge from hospital • Minimum oxygen saturation every day from admission to discharge from hospital • Maximum respiratory rate every day from admission to discharge from hospital • Maximum heart rate every day from admission to discharge from hospital • Hb levels in g / dl at H0 and H48 • Reticulocyte levels in G / L at H0 and H48 • Leukocyte count / mm3 at H0 and H48 • Polynuclear neutrophil count / mm3 at H0 and H48 • Platelet count in G / L at H0 and H48 • CRP in mg / L at H0 and H48 • TGO, TGP at H0 and H48 • Bilirubin at H0 and H48 • LDH at H0 and H48 • Substance rate P at H0 and H48 ;Timepoint(s) of evaluation of this end point: at H24, H48, H72 and every 24h until discharge | — |
Countries
France
Contacts
Public ContactPONDARRE
Centre Hospitalier Intercommunal de Créteil
Outcome results
None listed