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Low recruitment
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SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age.
The main location of the pain for 60% of children with CP was the lower limbs, caused by musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE 2, 50% of the children complained about pain during physical therapy.
If the pain is part of the management of physiotherapy, a recent review showed that for a condition such as chronic back pain, the level of evidence of the effectiveness of physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would include higher efficacy on anxiety than pain itself.
Despite significant involvement of physiotherapists in the management of pain, the focus on pain should increase, in particular taking into account the procedural/induced pain (caused by treatment).
In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to reduce the pain of children during medical procedures. For the latter most of them require the presence of two individuals to provide the therapy. This is unsuited for out-patient care provided to the majority of children with CP.
Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination with the treatment of several indications in child pain (migraine, postoperative pain, etc.). Ibuprofen is commonly used in children during painful procedures and represented the 4th molecule among prescribed per os analgesic drugs in 2008 in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Active ibuprofen |
|
| Placebo | Placebo Comparator | Placebo of ibuprofen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen) | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The pain reduction assessed by the Child health questionnaire | 5 months |
| Anxiety | The anxiety reduction assessed by a VAS scale. |
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Inclusion Criteria:
Exclusion Criteria:
Randomisation Criteria:
• Child who feel pain during the physiotherapy session with a mean VAS score above 3 during the screening phase.
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| Name | Affiliation | Role |
|---|---|---|
| Sylvain Brochard, Dr | University hospital of Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Morvan - CHRU Brest | Brest | 29609 | France | |||
| Hopitaux de Saint-Maurice |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo. |
|
| 5 months |
| Quality of life | The increase in quality of life assessed by the CP Child. | 5 months |
| Incidence of adverse events | 5 months |
| Saint-Maurice |
| 94410 |
| France |
| Ch Lannion-Trestel | Trévou-Tréguignec | 22660 | France |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |