Evaluation of the efficacy and safety of aprepitant in the management of vaso-occlusive crisis in sickle cell children: randomized, single-center, randomized, phase IIb/III prospective study - DREPADO

Centre Hospitalier Intercommunal de Créteil0 个研究点目标入组 60 人开始时间: 2019年4月24日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

Centre Hospitalier Intercommunal de Créteil