Clinical trial NCT02047591: Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.
Official title: Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Operation With the Settle of a Redon's Drain
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 232
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the score of pain, just after the removal of the Redon's drain
timeFrame: 5 minutes
Secondary outcomes:
measure: To compare, for 2 groups, the Score of pain: EVA scale (score 0-10).
timeFrame: 5 minutes
measure: Percentage of children with a pain rating ≥ 4
timeFrame: 5 minutes
measure: To compare, for 2 groups, the average level of EVA-anxiety scores
timeFrame: 5 minutes
measure: Proportion of children with a pain level ≥ 4 during removal of the drain
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Hospital
Study officials:
affiliation: University Hospital of Limoges
name: Laurent FOURCADE, MD
role: PRINCIPAL_INVESTIGATOR
References: