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