Chronic Postsurgical Pediatric Pain. Evaluation Risk Factors to Develop Chronic Postsurgical Pain in Children and Adolescents Undergoing Surgery in a First Level Hospital
NCT ID: NCT04735211
Last Updated: 2021-08-13
Study Results
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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UNKNOWN
260 participants
OBSERVATIONAL
2020-12-15
2021-12-15
Brief Summary
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To increase the body of knowledge, an observational study is proposed in pediatric patients undergoing surgical intervention.
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Detailed Description
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Before the surgical intervention, the risk factors described in the literature will be analyzed. Children will be followed up to 6 months after surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children whom develop chronic postsurgical pain
Children whom had chronic pain at 3 moths after surgery
Surgery
Pediatric Surgery with hospitalized
Children whom not develop chronic postsurgical pain
Children whom not develop chronic pain at 3 moths after surgery
No interventions assigned to this group
Interventions
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Surgery
Pediatric Surgery with hospitalized
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
18 Years
ALL
No
Sponsors
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Guillermo Ceniza Bordallo
OTHER
Responsible Party
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Guillermo Ceniza Bordallo
Principal Investigator
Locations
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Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
Madrid, , Spain
Countries
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References
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Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
Miro J, Huguet A, Nieto R. Predictive factors of chronic pediatric pain and disability: a Delphi poll. J Pain. 2007 Oct;8(10):774-92. doi: 10.1016/j.jpain.2007.04.009. Epub 2007 Jul 12.
Cai Y, Lopata L, Roh A, Huang M, Monteleone MA, Wang S, Sun LS. Factors influencing postoperative pain following discharge in pediatric ambulatory surgery patients. J Clin Anesth. 2017 Jun;39:100-104. doi: 10.1016/j.jclinane.2017.03.033. Epub 2017 Apr 1.
Taylor EM, Boyer K, Campbell FA. Pain in hospitalized children: a prospective cross-sectional survey of pain prevalence, intensity, assessment and management in a Canadian pediatric teaching hospital. Pain Res Manag. 2008 Jan-Feb;13(1):25-32. doi: 10.1155/2008/478102.
Nugraha B, Gutenbrunner C, Barke A, Karst M, Schiller J, Schafer P, Falter S, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: functioning properties of chronic pain. Pain. 2019 Jan;160(1):88-94. doi: 10.1097/j.pain.0000000000001433.
Rosenberg RE, Clark RA, Chibbaro P, Hambrick HR, Bruzzese JM, Feudtner C, Mendelsohn A. Factors Predicting Parent Anxiety Around Infant and Toddler Postoperative and Pain. Hosp Pediatr. 2017 Jun;7(6):313-319. doi: 10.1542/hpeds.2016-0166. Epub 2017 May 16.
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.
Voepel-Lewis T, Caird MS, Tait AR, Farley FA, Li Y, Malviya S, Hassett A, Weber M, Currier E, de Sibour T, Clauw DJ. A cluster of high psychological and somatic symptoms in children with idiopathic scoliosis predicts persistent pain and analgesic use 1 year after spine fusion. Paediatr Anaesth. 2018 Oct;28(10):873-880. doi: 10.1111/pan.13467.
Rosenbloom BN, Page MG, Isaac L, Campbell F, Stinson JN, Wright JG, Katz J. Pediatric Chronic Postsurgical Pain And Functional Disability: A Prospective Study Of Risk Factors Up To One Year After Major Surgery. J Pain Res. 2019 Nov 12;12:3079-3098. doi: 10.2147/JPR.S210594. eCollection 2019.
Ceniza-Bordallo G, Gomez Fraile A, Martin-Casas P, Rabbitts JA, Li R, Palermo TM, Lopez-de-Uralde-Villanueva I. Prevalence, pain trajectories, and presurgical predictors for chronic postsurgical pain in a pediatric sample in Spain with a 24-month follow-up. Pain. 2025 Jan 1;166(1):112-122. doi: 10.1097/j.pain.0000000000003330. Epub 2024 Jul 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20/618
Identifier Type: -
Identifier Source: org_study_id
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