4P: Persistent Postoperative Pediatric Pain
- Conditions
- Postoperative Pain
- Registration Number
- NCT06035042
- Lead Sponsor
- Region Halland
- Brief Summary
For children, adequate perioperative pain management is a right according to the UN convention on the rights of the child, a law in Sweden since 2020. Despite this, children are still under-treated in many cases. In addition to great suffering, this can lead to missing school and a long-term burden on the society.
ESPA, the European Society for Pediatric Anesthesia, has drawn up guidelines for perioperative pain management. With the study 4P: Persistent Postoperative Pediatric Pain, we want to investigate whether these guidelines are followed and how many children develop long-term pain postoperatively.
In order to map the prevalence of pain after surgery in children in Sweden, the investigators plan to include and follow 2000 children in southern Sweden who undergo surgery. The study provides a unique opportunity to follow a large number of children, evaluate given per- and postoperative pain treatment and identify factors linked to the development of acute and long-term postoperative pain. Our goal is to optimize peri- and postoperative pediatric pain management to promote rapid recovery after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Age 1-17 years
- Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden.
- Informed consent
- Scheduled for several surgeries within the time-frame
- Inability to understand swedish
- Inability to understand the meaning of participation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to guidelines from ESPA regarding perioperative analgesia Perioperative How many patients are treated according to the suggested guidelines regarding pain treatment from ESPA (%)? Do they experience less postoperative pain (FLACC/FPS/NRS 0-10)? Groups compared with MannWhitney U-test. Also description of the deviation.
Incidence of acute postoperative pain Within 24 hours after surgery How many children experience acute postoperative pain after surgery in Sweden?
Incidence of persistent postoperative pain At 1 year after surgery How many children experience persistent postoperative pain after surgery in Sweden?
- Secondary Outcome Measures
Name Time Method Gender Acute (24 hours) and persistent (3,6 months and 1 year) Do girls experience more pain than boys? Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.
Parental stress 3 months after surgery Does the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of persistent postoperative pain? Correlation between pain (FLACC/FPS/NRS depending on age) correlated to subjective stress using Spearman Rho.
Do regional blocks influence the level of acute postoperative pain? Acute - within 24 hours. Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.
Do regional blocks influence the level of persistent pain? 3 months after surgery Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.
Age Acute (24 hours) and persistent (3,6 months and 1 year) Which age-groups experience most pain. Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.
Trial Locations
- Locations (4)
Hallands Hospital Halmstad
🇸🇪Halmstad, Sweden
Helsingborgs Hospital
🇸🇪Helsingborg, Sweden
Queen Silvias Childrens Hospital Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Lund childrens hospital
🇸🇪Lund, Sweden