Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

NCT04206956 | Unknown

• 1 other identifier: CHSB-2019-05-P2-ANXIDOU
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Ambulatory Surgery; Children, Only; Inguinal Hernia; Umbilical Hernia; Urologic Surgery

Keywords

pediatric department; children; chronic postsurgical pain; perioperative anxiety

Outcome Measures

Primary Outcomes (4)

• Children's preoperative anxiety

  \- 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)

  Preoperative : day of surgery

• Parents' preoperative anxiety

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

  Preoperative: day of surgery

• children's pain

  * 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).

  postoperative: day of surgery

• Chronic postsurgical pain in children

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

  3 months after surgery

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing scheduled abdominal or urologic ambulatory surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Brieuc: lead

Study Sites (1)

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22027, France

RECRUITING

Related Publications (10)

• 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.

  PMID: 28363861 BACKGROUND

• 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.

  PMID: 28077537 BACKGROUND

• 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.

  PMID: 31335643 BACKGROUND

• 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.

  PMID: 23865442 BACKGROUND

• 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.

  PMID: 24109194 BACKGROUND

• 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.

  PMID: 26381701 BACKGROUND

• 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.

  PMID: 28598902 BACKGROUND

• 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.

  PMID: 22831892 BACKGROUND

• 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.

  PMID: 29352738 BACKGROUND

• 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.

  PMID: 23063345 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Umbilical; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Claire Barbarot, Dr

  Centre Hopsitalier Saint-Brieuc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwenaelle Le Garff, Dr

CONTACT

+33296017277; gwenaelle.legarff@armorsante.bzh

Catherine Bellot

CONTACT

+33296017340; catherine.bellot@armorsante.bzh

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 20, 2019
• Study Start: October 14, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

FR (1)