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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735211
Recruitment Status : Enrolling by invitation
First Posted : February 3, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Guillermo Ceniza Bordallo, Universidad Complutense de Madrid

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.


Condition or disease Intervention/treatment
Chronic Postoperative Pain Pediatric ALL Procedure: Surgery

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors to Develop Chronic Postsurgical Pediatric Pain: An Observational Study
Actual Study Start Date : December 15, 2020
Actual Primary Completion Date : May 3, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children whom develop chronic postsurgical pain
Children whom had chronic pain at 3 moths after surgery
Procedure: Surgery
Pediatric Surgery with hospitalized

Children whom not develop chronic postsurgical pain
Children whom not develop chronic pain at 3 moths after surgery



Primary Outcome Measures :
  1. Type of surgery [ Time Frame: 1 day presurgery ]
    Surgery Specialty.

  2. Previous pathologies [ Time Frame: 1 day presurgery ]
    Previous pathologies

  3. Baseline Child Catastrophizing [ Time Frame: 1 day presurgery ]
    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"

  4. Change of Child Catastrophizing at 3 moths postsurgery [ Time Frame: 3 months ]
    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"

  5. Change of Child Catastrophizing at 6 moths postsurgery [ Time Frame: 6 months ]
    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. Baseline Child Anxiety [ Time Frame: 1 day presurgery ]
    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.

  7. Change of Child Anxiety at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  8. Change of Child Anxiety at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  9. Baseline Pain Interference [ Time Frame: 1 day presurgery ]
    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.

  10. Change of Pain Interference at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  11. Change of Pain Interference at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  12. Baseline Child Fear of pain [ Time Frame: 1 day presurgery ]
    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.

  13. Change of Child Fear of pain at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  14. Change of Child Fear of pain at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  15. Baseline Child Kinesiophobia [ Time Frame: 1 day presurgery ]
    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.

  16. Change of Child Kinesiophobia at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  17. Change of Child Kinesiophobia at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  18. Baseline Health-related Quality of Life in Children [ Time Frame: 1 day presurgery ]
    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.

  19. Change of Health-related Quality of Life in Children at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  20. Change Health-related Quality of Life in Children at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  21. Baseline Pain intensity [ Time Frame: 1 day presurgery ]
    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.

  22. Change of Pain intensity 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  23. Change of Pain intensity at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.


Secondary Outcome Measures :
  1. Baseline Parent Anxiety [ Time Frame: 1 day presurgery ]
    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.

  2. Change of Parent Anxiety at 3 moths postsurgery [ Time Frame: 3 moths ]
    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. Change of Parent Anxiety at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  4. Baseline Parent Catastrophizing [ Time Frame: 1 day presurgery ]
    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"

  5. Change of Parent Catastrophizing at 3 months postsurgery [ Time Frame: 3 moths ]
    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. Change of Parent Catastrophizing at 6 months postsurgery [ Time Frame: 6 moths ]
    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"

  7. Baseline Parent Fear of pain [ Time Frame: 1 day presurgery ]
    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.

  8. Change of Parent Fear of pain at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  9. Change of Parent Fear of pain at 6 moths postsurgery [ Time Frame: 6 moths ]
    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.

  10. Baseline Parent Kinesiophobia [ Time Frame: 1 day presurgery ]
    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.

  11. Change of Parent Kinesiophobia at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  12. Change of Parent Kinesiophobia at 6 moths postsurgery [ Time Frame: Baseline, 3 moths, 6 months ]
    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.

  13. Baseline Health-related Quality of life in children [ Time Frame: 1 day presurgery ]
    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.

  14. Change of Health-related Quality of life in children at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  15. Change of Health-related Quality of life in children at 6 moths postsurgery [ Time Frame: 6 months ]
    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.

  16. Baseline Pain intensity assess by parents [ Time Frame: 1 day presurgery ]
    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.

  17. Change of Pain intensity assess by parents at 3 moths postsurgery [ Time Frame: 3 moths ]
    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.

  18. Change of Pain intensity assess by parents at 6 moths postsurgery [ Time Frame: 6 months ]
    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.


Other Outcome Measures:
  1. Age [ Time Frame: 1 day presurgery ]
    Age

  2. Sex [ Time Frame: 1 day presurgery ]
    Sex

  3. Weight [ Time Frame: 1 day presurgery ]
    Weight

  4. Level of education [ Time Frame: 1 day presurgery ]
    Child level of education

  5. Situation of dependence [ Time Frame: 1 day presurgery ]
    Child aid to dependency.

  6. Socioeconomic level [ Time Frame: 1 day presurgery ]
    Parents socioeconomic level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Pediatric Population undergoing surgical intervention.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735211


Locations
Layout table for location information
Spain
Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Guillermo Ceniza Bordallo
  Study Documents (Full-Text)

Documents provided by Guillermo Ceniza Bordallo, Universidad Complutense de Madrid:
Study Protocol  [PDF] December 15, 2020
Statistical Analysis Plan  [PDF] December 15, 2020
Informed Consent Form  [PDF] December 15, 2020

Publications of Results:

Layout table for additonal information
Responsible Party: Guillermo Ceniza Bordallo, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04735211    
Other Study ID Numbers: 20/618
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Ceniza Bordallo, Universidad Complutense de Madrid:
Chronic Postsurgical Pediatric Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations