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Clinical Trials/NCT04206956
NCT04206956
Unknown
Not Applicable

Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Centre Hospitalier de Saint-Brieuc1 site in 1 country135 target enrollmentOctober 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ambulatory Surgery
Sponsor
Centre Hospitalier de Saint-Brieuc
Enrollment
135
Locations
1
Primary Endpoint
Chronic postsurgical pain in children
Last Updated
6 years ago

Overview

Brief Summary

Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

Detailed Description

The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects. For children, there is few data about predictive factors of postoperative pain after ambulatory surgery. The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
September 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier de Saint-Brieuc
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • child from 3 to 18 years old
  • undergoing scheduled urology or abdominal ambulatory surgery
  • child and parents speaking French
  • affiliation to national health insurance

Exclusion Criteria

  • emergency surgery
  • lack of parents consent
  • no parental support on surgery day

Outcomes

Primary Outcomes

Chronic postsurgical pain in children

Time Frame: 3 months after surgery

For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)

Children's preoperative anxiety

Time Frame: Preoperative : day of surgery

- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale). If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child - For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)

Parents' preoperative anxiety

Time Frame: Preoperative: day of surgery

anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"

children's pain

Time Frame: postoperative: day of surgery

* for children younger than 6: Evendol scale. From 0 (better) to 15 (worse) * for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).

Study Sites (1)

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