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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04068350
Other study ID # CHUBX 2009/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 21, 2010
Est. completion date December 21, 2011

Study information

Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.


Description:

Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of the operated adults. The factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy.

In pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. On the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults.

This study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.


Recruitment information / eligibility

Status Completed
Enrollment 582
Est. completion date December 21, 2011
Est. primary completion date December 21, 2011
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the Bordeaux University Hospital.

All patients who consented to participate in the research.

Exclusion Criteria:

- All children operated on outpatient surgery.

- Children and parents with difficulties in understanding the questionnaires.

- Refusal of the child or one of the parents.

- Change of home planned during the post-operative follow-up period (3 months).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain questionnaire
Pain questionnaire, 3 months after surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic postoperative pain Visual analogic scale from 0 to 100: (between 0 and 30: low pain, between 30 and 60: moderate pain, between 60 and 100: severe pain) 3 months after surgery
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