Surgical Operation With the Settle of a Redon's Drain
Conditions
Brief summary
The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches. In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children. In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale \> or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.
Interventions
OTHERRelaxing-touch method
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children \> or = 7 and \< 18 years old * Hospitalization for surgery having required the settle of a Redon's drain during surgery. * The presence of at least one of the legal representatives with the child during the care. * The consent of at least one of the legal representatives and agreement of the child for the relaxing-touch method. * The affiliation of one of the legal guardian to the social security.
Exclusion criteria
* Children with an intellectual deficiency preventing the use of the scale EVA from the pain. * Children having already had one or several removal of the Redon's drain: the negative memory of the pain for a similar act could falsify the score of pain * Children refusing the usual care of the pain in the department by the MEOPA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the score of pain, just after the removal of the Redon's drain | 5 minutes | The score of pain, just after the removal of the Redon's drain, constitutes the main end point. It will be collected by the score of the EVA (scores from 0 to 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare, for 2 groups, the Score of pain: EVA scale (score 0-10). | 5 minutes | Score of pain: EVA scale (score 0-10). The 2 groups average EVA level will be compared. |
| Percentage of children with a pain rating ≥ 4 | 5 minutes | The Percentage of children with a pain rating ≥ 4 will be compared between the two groups in children aged 7 to 11 and 12 to 17 years old |
| To compare, for 2 groups, the average level of EVA-anxiety scores | 5 minutes | Comparison of the average level of "EVA-anxiety" scores in the two groups of children before treatment |
| Proportion of children with a pain level ≥ 4 during removal of the drain | 5 minutes | the proportion of children with a pain level ≥ 4 during removal of the drain in the group of children who underwent an orthopedic procedure; a visceral act; an act thoracic; an act for gynecomastia; an act for burn treatment by prosthesis expansion; |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurent FOURCADE, MD
University Hospital of Limoges
Outcome results
None listed