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

Pediatric ALL Clinical Trial

Official title:

Risk Factors to Develop Chronic Postsurgical Pediatric Pain: An Observational Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04735211
• Other study ID #: 20/618
• Status: Enrolling by invitation
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative
• Pediatric ALL

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