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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04735211
Other study ID # 20/618
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 15, 2020
Est. completion date December 15, 2021

Study information

Verified date August 2021
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

A cohort of pediatric patients undergoing surgery will be followed at the Maternal and Child Hospital October 12, Madrid. The group of patients that develops post-surgical chronic pain and the group that does not develop it will be observed, and risk factors will be studied. Before the surgical intervention, the risk factors described in the literature will be analyzed. Children will be followed up to 6 months after surgery.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 260
Est. completion date December 15, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Children who do not understand and speak Spanish correctly. Children with verbal communication problems.

Study Design


Intervention

Procedure:
Surgery
Pediatric Surgery with hospitalized

Locations

Country Name City State
Spain Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
Guillermo Ceniza Bordallo

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Huguet A, Miró J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. Epub 2007 Dec 21. — View Citation

Miró J, Huguet A, Nieto R. Predictive factors of chronic pediatric pain and disability: a Delphi poll. J Pain. 2007 Oct;8(10):774-92. Epub 2007 Jul 12. — View Citation

Nugraha B, Gutenbrunner C, Barke A, Karst M, Schiller J, Schäfer 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. — 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

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 — View Citation

Rosenbloom BN, Pagé 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: 1 — View Citation

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. — View Citation

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 ye — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Age Age 1 day presurgery
Other Sex Sex 1 day presurgery
Other Weight Weight 1 day presurgery
Other Level of education Child level of education 1 day presurgery
Other Situation of dependence Child aid to dependency. 1 day presurgery
Other Socioeconomic level Parents socioeconomic level 1 day presurgery
Primary Type of surgery Surgery Specialty. 1 day presurgery
Primary Previous pathologies Previous pathologies 1 day presurgery
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Baseline Parent Anxiety Assess by Pain Anxiety Symptoms Scale-Short Form (PASS-20) PASS-2022 consists of 20 items that measure the fear and anxiety-related thoughts, feelings, behaviors, and physical sensations that accompany the experience and anticipation of pain. Each item is rated on a scale of 0 (never) to 5 (always) and total scores range from 0 to 100. The PASS-20 has four subscales: cognitive, escape/avoidance, fear, and physiological anxiety. 1 day presurgery
Secondary Change of Parent Anxiety at 3 moths postsurgery Assess by Pain Anxiety Symptoms Scale-Short Form (PASS-20) PASS-2022 consists of 20 items that measure the fear and anxiety-related thoughts, feelings, behaviors, and physical sensations that accompany the experience and anticipation of pain. Each item is rated on a scale of 0 (never) to 5 (always) and total scores range from 0 to 100. The PASS-20 has four subscales: cognitive, escape/avoidance, fear, and physiological anxiety. 3 moths
Secondary Change of Parent Anxiety at 6 moths postsurgery Assess by Pain Anxiety Symptoms Scale-Short Form (PASS-20) PASS-2022 consists of 20 items that measure the fear and anxiety-related thoughts, feelings, behaviors, and physical sensations that accompany the experience and anticipation of pain. Each item is rated on a scale of 0 (never) to 5 (always) and total scores range from 0 to 100. The PASS-20 has four subscales: cognitive, escape/avoidance, fear, and physiological anxiety. 6 moths
Secondary Baseline Parent Catastrophizing The Pain Catastrophizing Scale-Parent report (PCS-P) is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-P 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 my child has pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When my child has pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When my child has pain, I feel like I can't go on" 1 day presurgery
Secondary Change of Parent Catastrophizing at 3 months postsurgery The Pain Catastrophizing Scale-Parent report (PCS-P) is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-P 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 my child has pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When my child has pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When my child has pain, I feel like I can't go on" 3 moths
Secondary Change of Parent Catastrophizing at 6 months postsurgery The Pain Catastrophizing Scale-Parent report (PCS-P) is a validated self-report measure that is used to assess negative thinking associated with pain. The PCS-P 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 my child has pain, I can't keep it out of my mind"), magnification (3 items, e.g. "When my child has pain, I keep thinking of other painful events") and helplessness (6 items, e.g. "When my child has pain, I feel like I can't go on" 6 moths
Secondary Baseline Parent Fear of pain Assess by The Fear of Pain Questionnaire-Parents (FOPQ-P): Is a validated self-report measure that used to asses fear of pain in parents with his children are in pain. The FOPQ-P include 24 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across three subscales: fear of pain, avoidance of activities and school avoidance. 1 day presurgery
Secondary Change of Parent Fear of pain at 3 moths postsurgery Assess by The Fear of Pain Questionnaire-Parents (FOPQ-P): Is a validated self-report measure that used to asses fear of pain in parents with his children are in pain. The FOPQ-P include 24 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across three subscales: fear of pain, avoidance of activities and school avoidance. 3 moths
Secondary Change of Parent Fear of pain at 6 moths postsurgery Assess by The Fear of Pain Questionnaire-Parents (FOPQ-P): Is a validated self-report measure that used to asses fear of pain in parents with his children are in pain. The FOPQ-P include 24 ítems, which are rated on a 5-point scale ranging 0=" not at all" 5="very true". The items are divided across three subscales: fear of pain, avoidance of activities and school avoidance. 6 moths
Secondary Baseline Parent 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
Secondary Change of Parent 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
Secondary Change of Parent 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. Baseline, 3 moths, 6 months
Secondary Baseline Health-related Quality of life in children Assess by Pediatric Quality of Life version 4.0 Parent Version (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items, parent proxy-report forms of quality of life in younger children. Parent proxy reports have also been used for children in the age range from 2-18 years. 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
Secondary Change of Health-related Quality of life in children at 3 moths postsurgery Assess by Pediatric Quality of Life version 4.0 Parent Version (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items, parent proxy-report forms of quality of life in younger children. Parent proxy reports have also been used for children in the age range from 2-18 years. 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
Secondary Change of Health-related Quality of life in children at 6 moths postsurgery Assess by Pediatric Quality of Life version 4.0 Parent Version (PedsQL 4.0), which is a widely used measure of health-related quality of life in children. The PedsQL consists of 23-items, parent proxy-report forms of quality of life in younger children. Parent proxy reports have also been used for children in the age range from 2-18 years. 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 months
Secondary Baseline Pain intensity assess by parents Asees by Parents' Postoperative Pain Measure (PPPM). The PPPM is completed by parents to assess children's pain following surgery and is the only validated measure of parent-report postoperative pain severity in children. Parents are asked to indicate the presence or absence of each of 15 behavioral indicators of pain. 1 day presurgery
Secondary Change of Pain intensity assess by parents at 3 moths postsurgery Asees by Parents' Postoperative Pain Measure (PPPM). The PPPM is completed by parents to assess children's pain following surgery and is the only validated measure of parent-report postoperative pain severity in children. Parents are asked to indicate the presence or absence of each of 15 behavioral indicators of pain. 3 moths
Secondary Change of Pain intensity assess by parents at 6 moths postsurgery Asees by Parents' Postoperative Pain Measure (PPPM). The PPPM is completed by parents to assess children's pain following surgery and is the only validated measure of parent-report postoperative pain severity in children. Parents are asked to indicate the presence or absence of each of 15 behavioral indicators of pain. 6 months
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