NCT06035042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

May 29, 2023

Last Update Submit

January 27, 2026

Conditions

Postoperative Pain

Keywords

Pediatric pain

Outcome Measures

Primary Outcomes (5)

  • Incidence of acute postoperative pain

    How many children experience acute postoperative pain after surgery in Sweden?

    Within 24 hours after surgery

  • Adherence to guidelines from ESPA regarding perioperative analgesia

    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.

    Perioperative

  • Incidence of persistent postoperative pain

    How many children experience persistent postoperative pain after surgery in Sweden?

    At 3 months after surgery

  • Incidence of persistent postoperative pain

    How many children experience persistent postoperative pain after surgery in Sweden?

    At 6 months after surgery

  • Incidence of persistent postoperative pain

    How many children experience persistent postoperative pain after surgery in Sweden?

    At 1 year after surgery

Secondary Outcomes (6)

  • Do regional blocks influence the level of acute postoperative pain?

    Acute - within 24 hours.

  • Do regional blocks influence the level of persistent pain?

    3 months after surgery

  • Parental stress

    Within 24 hours

  • Parental stress

    3 months after surgery

  • Age

    Acute (24 hours) and persistent (3,6 months and 1 year)

  • +1 more secondary outcomes

Interventions

Scheduled surgeryPROCEDURE

All subjects will be exposed to surgery

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with planned surgery in southern Sweden for by ESPA specified types of surgeries.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Queen Silvias Childrens Hospital Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Hallands Hospital Halmstad

Halmstad, 30572, Sweden

Location

Helsingborgs Hospital

Helsingborg, Sweden

Location

Lund childrens hospital

Lund, Sweden

Location

Related Publications (1)

  • Broman J, Nielsen N, Persson AKM. A prospective observational study on persistent postoperative pediatric pain, 4P: The study protocol. PLoS One. 2025 Jan 14;20(1):e0316533. doi: 10.1371/journal.pone.0316533. eCollection 2025.

    PMID: 39808613DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Anna KM Persson, MD, PhD

    Region Halland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Anaesthesia and Intensive Care Medicine, PhD

Study Record Dates

First Submitted

May 29, 2023

First Posted

September 13, 2023

Study Start

September 1, 2023

Primary Completion

September 28, 2024

Study Completion

January 28, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(4)