Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

NCT ID: NCT04206956

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-09-30

Brief Summary

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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

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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)

Conditions

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Ambulatory Surgery Children, Only Inguinal Hernia Umbilical Hernia Urologic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Saint-Brieuc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Barbarot, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hopsitalier Saint-Brieuc

Locations

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Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gwenaelle Le Garff, Dr

Role: CONTACT

+33296017277

Catherine Bellot

Role: CONTACT

+33296017340

Facility Contacts

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Gwenaƫlle Le Garff

Role: primary

+33296017277

Catherine Bellot

Role: backup

+33296017340

References

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Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.

Reference Type BACKGROUND
PMID: 28363861 (View on PubMed)

Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.

Reference Type BACKGROUND
PMID: 28077537 (View on PubMed)

Noel M, Rosenbloom B, Pavlova M, Campbell F, Isaac L, Page MG, Stinson J, Katz J. Remembering the pain of surgery 1 year later: a longitudinal examination of anxiety in children's pain memory development. Pain. 2019 Aug;160(8):1729-1739. doi: 10.1097/j.pain.0000000000001582.

Reference Type BACKGROUND
PMID: 31335643 (View on PubMed)

Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.

Reference Type BACKGROUND
PMID: 23865442 (View on PubMed)

Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.

Reference Type BACKGROUND
PMID: 24109194 (View on PubMed)

Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.

Reference Type BACKGROUND
PMID: 26381701 (View on PubMed)

Birnie KA, Chorney J, El-Hawary R; PORSCHE Study Group. Child and parent pain catastrophizing and pain from presurgery to 6 weeks postsurgery: examination of cross-sectional and longitudinal actor-partner effects. Pain. 2017 Oct;158(10):1886-1892. doi: 10.1097/j.pain.0000000000000976.

Reference Type BACKGROUND
PMID: 28598902 (View on PubMed)

Kristensen AD, Ahlburg P, Lauridsen MC, Jensen TS, Nikolajsen L. Chronic pain after inguinal hernia repair in children. Br J Anaesth. 2012 Oct;109(4):603-8. doi: 10.1093/bja/aes250. Epub 2012 Jul 24.

Reference Type BACKGROUND
PMID: 22831892 (View on PubMed)

Mossetti V, Boretsky K, Astuto M, Locatelli BG, Zurakowski D, Lio R, Nicoletti R, Sonzogni V, Maffioletti M, Vicchio N, Ivani G. Persistent pain following common outpatient surgeries in children: A multicenter study in Italy. Paediatr Anaesth. 2018 Mar;28(3):231-236. doi: 10.1111/pan.13321. Epub 2018 Jan 20.

Reference Type BACKGROUND
PMID: 29352738 (View on PubMed)

Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.

Reference Type BACKGROUND
PMID: 23063345 (View on PubMed)

Other Identifiers

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CHSB-2019-05-P2-ANXIDOU

Identifier Type: -

Identifier Source: org_study_id

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