Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Hôpital Necker-Enfants Malades
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Change of EVENDOL from day1 at day2
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Marion Hery
Osteopath
Hôpital Necker-Enfants Malades
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
Outcomes
Primary Outcomes
Change of EVENDOL from day1 at day2
Time Frame: day 2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
Secondary Outcomes
- Change of EVENDOL from day1 at day2(day 2)
- Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy(day 2)
- Change of Faces scale or Visual analog scale from day1 at day2(day 2)
- Change of Arterial Pressure from day1 at day2(Day 2)
- Change of Oxygen saturation from day1 at day2(day2)
- Change of cardiac frequency from day1 at day2(day 2)
- Change of cardiac breathing frequency from day1 at day2(day2)
- Analgesic intake at day1(day1)
- Analgesic intake at day2(day2)