Post-operative pain in children with cerebral palsy following major hip surgery: a double blind randomised placebo controlled trial of pre-operative Botulinum toxin type A. [The Post-Operative Pain in cerebral Palsy (POPPIES) trial] - The Post-Operative Pain in cerebral Palsy (POPPIES) trial

Guys and St Thomas' NHS Foundation Trust0 个研究点目标入组 54 人开始时间: 2011年3月2日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.The child has displaced hips requiring bony orthopaedic surgery (osteotomy) due to cerebral palsy.
•2.The child is between the ages of 2 and 18 years.
•3.The child has a GMFCS level of IV or V
•4.The child has a diagnosis of hypertonic cerebral palsy (or a diagnosis consistent with this nomenclature)
•5.The child does not communicate verbally
•6.Informed consent to participate has been given by parent/carer.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•1.The child is younger than 2 years or older than 18 years
•2.The child has an acute and current systemic infection or illness
•3.The child has had botulinum toxin injections within the past 4 months
•4.The child has had a previous reaction to botulinum toxin
•5.The child has received or is likely to receive, at the time of trial drug or placebo administration, medications which might interact with botulinum toxin (this does not apply to any drugs at present)
•6.Insufficient understanding of the trial by the parent or carer, in the investigator’s opinion.

发起方

Guys and St Thomas' NHS Foundation Trust