Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP) (ANTALKINECP)

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

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy
• Intervention / Treatment: Drug: Ibuprofen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Hôpital Morvan - CHRU Brest
  • Saint-Maurice, France, 94410
    • Hôpitaux de Saint-Maurice
  • Trevou-Treguignec, France, 22660
    • Ch Lannion-Trestel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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).

Exclusion Criteria:

• 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)
• The last botulinum toxin injection in two months before the inclusion
• Child who feel pain with EVA score superior or equal to 4 at the time of the inclusion outside the sessions of physiotherapy
• 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

Randomisation Criteria:

• Child who feel pain during the physiotherapy session with a mean VAS score above 3 during the screening phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen; Active ibuprofen	Drug: Ibuprofen; 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.; Other Names: AdvilMed
Placebo Comparator: Placebo; Placebo of ibuprofen	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	5 months
Quality of life	The increase in quality of life assessed by the CP Child.	5 months
Incidence of adverse events		5 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Sylvain Brochard, Dr, University Hospital of Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): September 19, 2018

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Children; Physiotherapy; Cerebral palsy; Ibuprofen
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: ANTALKINECP RB15.213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No