Clinical trial NCT04735211: Chronic Postsurgical Pediatric Pain. Evaluation Risk Factors to Develop Chronic Postsurgical Pain in Children and Adolescents Undergoing Surgery in a First Level Hospital
Official title: Risk Factors to Develop Chronic Postsurgical Pediatric Pain: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Postoperative Pain
Pediatric ALL
Keywords: Chronic Postsurgical Pediatric Pain
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 260
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric Population undergoing surgical intervention.

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.

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.

Primary outcomes:
measure: Type of surgery
timeFrame: 1 day presurgery
measure: Previous pathologies
timeFrame: 1 day presurgery
measure: Baseline Child Catastrophizing
timeFrame: 1 day presurgery
measure: Change of Child Catastrophizing at 3 moths postsurgery
timeFrame: 3 months
measure: Change of Child Catastrophizing at 6 moths postsurgery
timeFrame: 6 months
measure: Baseline Child Anxiety
timeFrame: 1 day presurgery
measure: Change of Child Anxiety at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Child Anxiety at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Pain Interference
timeFrame: 1 day presurgery
measure: Change of Pain Interference at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Pain Interference at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Child Fear of pain
timeFrame: 1 day presurgery
measure: Change of Child Fear of pain at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Child Fear of pain at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Child Kinesiophobia
timeFrame: 1 day presurgery
measure: Change of Child Kinesiophobia at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Child Kinesiophobia at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Health-related Quality of Life in Children
timeFrame: 1 day presurgery
measure: Change of Health-related Quality of Life in Children at 3 moths postsurgery
timeFrame: 3 moths
measure: Change Health-related Quality of Life in Children at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Pain intensity
timeFrame: 1 day presurgery
measure: Change of Pain intensity 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Pain intensity at 6 moths postsurgery
timeFrame: 6 moths
Secondary outcomes:
measure: Baseline Parent Anxiety
timeFrame: 1 day presurgery
measure: Change of Parent Anxiety at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Parent Anxiety at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Parent Catastrophizing
timeFrame: 1 day presurgery
measure: Change of Parent Catastrophizing at 3 months postsurgery
timeFrame: 3 moths
measure: Change of Parent Catastrophizing at 6 months postsurgery
timeFrame: 6 moths
measure: Baseline Parent Fear of pain
timeFrame: 1 day presurgery
measure: Change of Parent Fear of pain at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Parent Fear of pain at 6 moths postsurgery
timeFrame: 6 moths
measure: Baseline Parent Kinesiophobia
timeFrame: 1 day presurgery
measure: Change of Parent Kinesiophobia at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Parent Kinesiophobia at 6 moths postsurgery
timeFrame: Baseline, 3 moths, 6 months
measure: Baseline Health-related Quality of life in children
timeFrame: 1 day presurgery
measure: Change of Health-related Quality of life in children at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Health-related Quality of life in children at 6 moths postsurgery
timeFrame: 6 months
measure: Baseline Pain intensity assess by parents
timeFrame: 1 day presurgery
measure: Change of Pain intensity assess by parents at 3 moths postsurgery
timeFrame: 3 moths
measure: Change of Pain intensity assess by parents at 6 moths postsurgery
timeFrame: 6 months
Other outcomes:
measure: Age
timeFrame: 1 day presurgery
measure: Sex
timeFrame: 1 day presurgery
measure: Weight
timeFrame: 1 day presurgery
measure: Level of education
timeFrame: 1 day presurgery
measure: Situation of dependence
timeFrame: 1 day presurgery
measure: Socioeconomic level
timeFrame: 1 day presurgery
Locations:
city: Madrid
country: Spain
facility: Faculty of Nurse, Physiotherapy and Podiatry. University Complutense of Madrid
Study officials:
References:
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