Analgesia and physiotherapy in children with cerebral palsy (ANTALKINECP): Double blind cross-over placebo controlled study of Ibuprofen in children with cerebral palsy undergoing physiotherapy - ANTALKINECP

CHRU de Brest0 个研究点目标入组 180 人开始时间: 2016年3月2日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Cerebral palsy hemiplegic diplegic or tetraplegic spastic or not.
•Children who feel pain during the pre-screening physiotherapy session with a VAS score above 2 (or 1 on the FPS).
•Aged 6 to 17 years of both gender.
•Ability to express his/her pain and to measure its intensity with VAS or FPS.
•Informed and signed (parents, investigator and child if possible).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 180
•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

•Lack of physiotherapy or frequency below every fortnight.
•Analgesic treatment already available or stopped in the last month.
•Severe infection or instable vital functions.
•Child unable to cooperate.
•Hypersensitivity to ibuprofen or any of the constituents in the product.
•History of allergy or asthma triggered by taking ibuprofen or substances of near activity such as other NSAIDs and aspirin.
•Allergy to other component of the capsule.
•Allergy or intolerance to lactose
•History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
•Active gastrointestinal ulcer.
•Severe hepatic failure.
•Severe renal failure.
•Uncontrolled severe cardiac failure.
•Systemic Lupus Erythematosus.
•Scheduled surgery procedure during or between the period of the assessment of pain
•Regular intake of ibuprofen

发起方

CHRU de Brest