Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP)

NCT02839785 | Terminated Phase 3

• 1 other identifier: ANTALKINECP RB15.213
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Physiotherapy; Children; Ibuprofen; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen)

  5 months

Secondary Outcomes (4)

• Pain

  5 months

• Anxiety

  5 months

• Quality of life

  5 months

• Incidence of adverse events

  5 months

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Active ibuprofen

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Placebo of ibuprofen

Drug: Placebo

Interventions

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.

Also known as: AdvilMed

Ibuprofen

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.

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Aged 6 to 17 years of both gender.
• Ability to express his/her pain and to measure its intensity with VAS.
• Informed and signed (parents, investigator and child if possible).

You may not qualify if:

• Lack of physiotherapy.
• Analgesic treatment already available or stopped in the last month.
• Scheduled surgery procedure or botulinum toxin injection during the period of the assessment of pain (around 5 month)
• Child unable to cooperate.
• Severe infection or instable vital functions.
• 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 treatment.
• 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.
• Regular intake of ibuprofen

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

Hôpital Morvan - CHRU Brest

Brest, 29609, France

Location

Hopitaux de Saint-Maurice

Saint-Maurice, 94410, France

Location

Ch Lannion-Trestel

Trévou-Tréguignec, 22660, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Pain; Anxiety Disorders

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Sylvain Brochard, Dr

  University hospital of Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 21, 2016
• Study Start: March 29, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

FR (3)