Cerebral Palsy MedDRA version: 18.1 Level: PT Classification code 10008129 Term: Cerebral palsy System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: ADVILMED 20 mg/ml
Product Name: Ibuprofen
Pharmaceutical Form: Oral suspension
INN or Proposed INN: IBUPROFEN
CAS Number: 15
Sponsors
CHRU de Brest
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the effectiveness of ibuprofen versus placebo on the pain caused by physical therapy in children with cerebral palsy evaluated by reducing the score of visual analogue scale (VAS);Primary end point(s): Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen).; Secondary Objective: • Assess the safety and side effects of ibuprofen administered as a single daily preventive dose. • Determine whether the pain medication given prior to the physiotherapy session: - Decreases anxiety assessed by VAS before the physiotherapy session. - Decreases at the end of treatment period: o anxiety assessed by the Yale preoperative anxiety scale. o the overall perception of the pain during the week before assessed by the pain section of Child health questionnaire. o spasticity of four members assessed by the score Ashworth scale. - Increases the ability of muscle to be stretched at the end of the treatment period evaluated by measuring joint angles with a goniometer. ;Timepoint(s) of evaluation of this end point: A the end of the study ( 20 physiotherapy session) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other criteria will be subject to statistical analysis and if necessary a subgroup analysis. Will be considered as secondary endpoints: •The pain reduction assessed by the Child health questionnaire. •The anxiety reduction assessed by a VAS and the Yale preoperative anxiety scale. •The increase in quality of life assessed by the CP Child. •The incidence of adverse events. ;Timepoint(s) of evaluation of this end point: A the end of the study ( 20 physiotherapy session) | — |
Countries
France
Contacts
Public ContactDRCI
CHRU de Brest
Outcome results
None listed