Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Inguinal Hernia Clinical Trial

— ANXIDOU  

Official title:

Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206956
• Other study ID #: CHSB-2019-05-P2-ANXIDOU
• Status: Recruiting
• Start date: October 14, 2019
• Est. completion date: September 2020

Study information

• Verified date: January 2020
• Source: Centre Hospitalier de Saint-Brieuc
• Contact: Gwenaelle Le Garff, Dr
• Phone: +33296017277
• Email: gwenaelle.legarff[@]armorsante.bzh
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Brieuc	Saint-Brieuc

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Brieuc

Country where clinical trial is conducted

France, 

References & Publications (10)

Batoz H, Semjen F, Bordes-Demolis M, Bénard 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Noel M, Rosenbloom B, Pavlova M, Campbell F, Isaac L, Pagé 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. — View Citation

Pagé 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. — View Citation

Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araújo-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. — View Citation

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. Review. — View Citation

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):2383-9. doi: 10.1097/j.pain.0000000000000281. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Parents' preoperative anxiety	anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"	Preoperative: day of surgery
Primary	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
Primary	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