Clinical trial NCT02710825: Osteopathy and Children With Congenital Heart Disease Surgery
Official title: Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
Collaborators: name: ARCFA : Association for research in cardiology foetal to adult
First posted: 2016-03-17
Enrollment: 113
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease

Detailed description: The management of pain in children after cardiac surgery is the key to ensure a better comfort and fast home return.

Aside drugs and psychology or physical therapy, no other alternative is proposed in the medico-surgical unit of pediatric cardiology at the Necker hospital.

Following a feasibility study within the department, osteopathic care showed significant pain reduction in postoperative surgery assessed through the EVENDOL scale.

The goal was mainly to improve mobility restricted areas due to the operation, and so help to reduce post-operative pain.

Investigators propose to continue the assessment of the overall osteopathic taking care of the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population will include children from the age of 5 days to less than 7 years old.

Eligibility criteria: Inclusion Criteria:

* Children aged 5 days to 7 years old
* Congenital heart sternotomy or thoracotomy operated
* Postoperative management at the Necker hospital in Paris, followed by Professor Damien Bonnet team
* Agreeing to participate of one of the holders of parental authority
* Oral Agreement child age
* Minimal knowledge of French language by parents
* Covered by the French social security system

Exclusion Criteria:

* Heart disease treated by interventional catheterization
* Postoperative complications requiring more than three weeks of intensive care
* Participation in an other biomedical research protocol
* Refusal or linguistic or mental disabilities or parents of the child

Primary outcomes:
measure: Change of EVENDOL from day1 at day2
timeFrame: day 2
Secondary outcomes:
measure: Change of EVENDOL from day1 at day2
timeFrame: day 2
measure: Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy
timeFrame: day 2
measure: Change of Faces scale or Visual analog scale from day1 at day2
timeFrame: day 2
measure: Change of Arterial Pressure from day1 at day2
timeFrame: Day 2
measure: Change of Oxygen saturation from day1 at day2
timeFrame: day2
measure: Change of cardiac frequency from day1 at day2
timeFrame: day 2
measure: Change of cardiac breathing frequency from day1 at day2
timeFrame: day2
measure: Analgesic intake at day1
timeFrame: day1
measure: Analgesic intake at day2
timeFrame: day2
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Fanny Bajolle, Ph
role: STUDY_DIRECTOR
References:
citation: Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12.
citation: Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006 Jun;106(6):327-34.