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Clinical Trials/NCT04735211
NCT04735211
Unknown
N/A

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

Guillermo Ceniza Bordallo1 site in 1 country260 target enrollmentDecember 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Postoperative Pain
Sponsor
Guillermo Ceniza Bordallo
Enrollment
260
Locations
1
Primary Endpoint
Type of surgery
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2020
End Date
December 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guillermo Ceniza Bordallo
Responsible Party
Sponsor Investigator
Principal Investigator

Guillermo Ceniza Bordallo

Principal Investigator

Universidad Complutense de Madrid

Eligibility 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.

Outcomes

Primary Outcomes

Type of surgery

Time Frame: 1 day presurgery

Surgery Specialty.

Previous pathologies

Time Frame: 1 day presurgery

Previous pathologies

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"

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"

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"

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Outcomes

  • Baseline Parent Anxiety(1 day presurgery)
  • Change of Parent Anxiety at 3 moths postsurgery(3 moths)
  • Change of Parent Anxiety at 6 moths postsurgery(6 moths)
  • Baseline Parent Catastrophizing(1 day presurgery)
  • Change of Parent Catastrophizing at 3 months postsurgery(3 moths)
  • Change of Parent Catastrophizing at 6 months postsurgery(6 moths)
  • Baseline Parent Fear of pain(1 day presurgery)
  • Change of Parent Fear of pain at 3 moths postsurgery(3 moths)
  • Change of Parent Fear of pain at 6 moths postsurgery(6 moths)
  • Baseline Parent Kinesiophobia(1 day presurgery)
  • Change of Parent Kinesiophobia at 3 moths postsurgery(3 moths)
  • Change of Parent Kinesiophobia at 6 moths postsurgery(Baseline, 3 moths, 6 months)
  • Change of Pain intensity assess by parents at 3 moths postsurgery(3 moths)
  • Baseline Health-related Quality of life in children(1 day presurgery)
  • Change of Health-related Quality of life in children at 3 moths postsurgery(3 moths)
  • Change of Health-related Quality of life in children at 6 moths postsurgery(6 months)
  • Baseline Pain intensity assess by parents(1 day presurgery)
  • Change of Pain intensity assess by parents at 6 moths postsurgery(6 months)

Study Sites (1)

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