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4P: Persistent Postoperative Pediatric Pain

4P: Persistent Postoperative Pediatric Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06035042
Acronym
4P
Enrollment
1000
Registered
2023-09-13
Start date
2023-09-01
Completion date
2026-01-28
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Pediatric pain

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.

Interventions

All subjects will be exposed to surgery

Sponsors

Region Halland
Lead SponsorOTHER
Lund University
CollaboratorOTHER
Region Skane
CollaboratorOTHER
Vastra Gotaland Region
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age 1-17 years * Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden. * Informed consent

Exclusion criteria

* Scheduled for several surgeries within the time-frame * Inability to understand swedish * Inability to understand the meaning of participation.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of acute postoperative painWithin 24 hours after surgeryHow many children experience acute postoperative pain after surgery in Sweden?
Adherence to guidelines from ESPA regarding perioperative analgesiaPerioperativeHow 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 persistent postoperative painAt 3 months after surgeryHow many children experience persistent postoperative pain after surgery in Sweden?

Secondary

MeasureTime frameDescription
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 surgeryDo children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.
Parental stressWithin 24 hoursDoes the subjective level of stress, measured on a scale from 0-10 by the parents, affect the experience of acute postoperative pain? Correlation between pain (FLACC/FPS/NRS depending on age) correlated to subjective stress using Spearman Rho.
AgeAcute (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.
GenderAcute (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.

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORAnna KM Persson, MD, PhD

Region Halland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026