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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Postoperative Pain, Pediatric ALL

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children whom develop chronic postsurgical pain<br>Children whom had chronic pain at 3 moths after surgery | Procedure: Surgery<br>* Pediatric Surgery with hospitalized<br>|
| Children whom not develop chronic postsurgical pain<br>Children whom not develop chronic pain at 3 moths after surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Postsurgical Pediatric Pain