Chronic Postsurgical Pediatric Pain. Evaluation Risk Factors to Develop Chronic Postsurgical Pain in Children and Adolescents Undergoing Surgery in a First Level Hospital

NCT04735211 | Unknown

• 1 other identifier: 20/618
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic postsurgical pain had number of prevalence on 20%. Its derivates from risk factors, but recent research provide new potential risk factors to develop chronic postsurgical pediatric pain. To increase the body of knowledge, an observational study is proposed in pediatric patients undergoing surgical intervention.

Conditions

Chronic Postoperative Pain; Pediatric ALL

Keywords

Chronic Postsurgical Pediatric Pain

Outcome Measures

Primary Outcomes (23)

• Type of surgery

  Surgery Specialty.

  1 day presurgery

• Previous pathologies

  Previous pathologies

  1 day presurgery

• Baseline Child Catastrophizing

  Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

  1 day presurgery

• Change of Child Catastrophizing at 3 moths postsurgery

  Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

  3 months

• Change of Child Catastrophizing at 6 moths postsurgery

  Assess by Child Catastrophizing scale.The Pain Catastrophizing Scale-Child (PCS-C);is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-C include 13 items, which are rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true." The items are divided across three subscales: rumination (4 items, e.g. "When I have pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When I have pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When I have pain, I feel like I can't go on"

  6 months

• Baseline Child Anxiety

  Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

  1 day presurgery

• Change of Child Anxiety at 3 moths postsurgery

  Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

  3 moths

• Change of Child Anxiety at 6 moths postsurgery

  Assess by Child Anxiety Symptoms Scale (CPASS) is a 20-item scale for children adapted from the adult PASS-20. For each statement, children are asked to rate the extent to which they think, act, or feel that way on a scale from 0 (''never think, act or feel that way'') to 5 (''always think, act, or feel that way''). Total scores range from 0 to 100, with higher scores indicating higher levels of pain anxiety.

  6 moths

• Baseline Pain Interference

  Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

  1 day presurgery

• Change of Pain Interference at 3 moths postsurgery

  Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

  3 moths

• Change of Pain Interference at 6 moths postsurgery

  Asess by PROMIS-Pediatric Pain Interference Scale (PPIS): The 8-item PPIS assesses how the child's pain has interfered with certain aspects of their life over the past 7 days (eg, sleep, attention, schoolwork, physical activities, emotion). Each item is rated on a 5-point scale ranging from "never" to "almost always". Scores range from 0 to 32 where higher scores indicate greater pain-related functional impairment.

  6 moths

• Baseline Child Fear of pain

  Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

  1 day presurgery

• Change of Child Fear of pain at 3 moths postsurgery

  Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

  3 moths

• Change of Child Fear of pain at 6 moths postsurgery

  Assess by The Fear of Pain Questionnaire-Children (FOPQ-C): Is a validated self-report measure that used to asses fear of pain in children. The FOPQ-C include 23 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across two subscales: fear of pain, and avoidance activities.

  6 moths

• Baseline Child Kinesiophobia

  Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

  1 day presurgery

• Change of Child Kinesiophobia at 3 moths postsurgery

  Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

  3 moths

• Change of Child Kinesiophobia at 6 moths postsurgery

  Assess by The Tampa Scale Kinesiophobia (TSK-11). Is a 11-item scale that measures fear of move- ment-evoked pain and injury. Scale items ranges from 0 (strongly disagree) to 4 (strongly agree) with 4 reversed- scored items. Total scores range from 25 to 56 with higher scores indicative of a greater fear of movement.

  6 moths

• Baseline Health-related Quality of Life in Children

  Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

  1 day presurgery

• Change of Health-related Quality of Life in Children at 3 moths postsurgery

  Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

  3 moths

• Change Health-related Quality of Life in Children at 6 moths postsurgery

  Pediatric Quality of Life version 4.0 (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items and includes both child-report (for those age 8 and over). The PedsQL assesses the following four domains of functioning: physical, emotional, social, and school and items are rated on a five-point Likert-type scale that ranges from 0 (never a problem) to 4 (almost always a problem). Items are converted to create a 0-100 scale, with higher scores reflecting higher quality of life.

  6 moths

• Baseline Pain intensity

  Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

  1 day presurgery

• Change of Pain intensity 3 moths postsurgery

  Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

  3 moths

• Change of Pain intensity at 6 moths postsurgery

  Assess by The Numerical Rating Scale (NRS) is a verbally administered scale that measures pain intensity (''how much pain do you feel right now?''). The NRS can also be used to measure pain unpleas- antness (''how unpleasant/horrible/yucky is the pain right now?''). The end points represent the extremes of the pain experience.

  6 moths

Secondary Outcomes (18)

• Baseline Parent Anxiety

  1 day presurgery

• Change of Parent Anxiety at 3 moths postsurgery

  3 moths

• Change of Parent Anxiety at 6 moths postsurgery

  6 moths

• Baseline Parent Catastrophizing

  1 day presurgery

• Change of Parent Catastrophizing at 3 months postsurgery

  3 moths

Other Outcomes (6)

• Age

  1 day presurgery

• Sex

  1 day presurgery

• Weight

  1 day presurgery

Study Arms (2)

Children whom develop chronic postsurgical pain

Children whom had chronic pain at 3 moths after surgery

Procedure: Surgery

Children whom not develop chronic postsurgical pain

Children whom not develop chronic pain at 3 moths after surgery

Interventions

Surgery PROCEDURE

Pediatric Surgery with hospitalized

Children whom develop chronic postsurgical pain

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric Population undergoing surgical intervention.

You may qualify if:

• Children with age from 4 years to 18 years. Undergoing surgery for any surgical specialty. ASA Status (American Society of Anesthesiologist) from I to III.

You may not qualify if:

• Children who do not understand and speak Spanish correctly. Children with verbal communication problems.

Sponsors & Collaborators

• Guillermo Ceniza Bordallo: lead

Study Sites (1)

Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid

Madrid, 28040, Spain

Location

Related Publications (10)

• 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.

  PMID: 18088558 RESULT

• 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.

  PMID: 17627893 RESULT

• 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.

  PMID: 28494878 RESULT

• 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.

  PMID: 18301813 RESULT

• 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.

  PMID: 30586076 RESULT

• 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.

  PMID: 28512138 RESULT

• 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 RESULT

• 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.

  PMID: 30302887 RESULT

• 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.

  PMID: 31814752 RESULT

• 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.

  PMID: 39047258 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 3, 2021
• Study Start: December 15, 2020
• Primary Completion: May 3, 2021
• Study Completion: December 15, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

ES (1)