4P: Persistent Postoperative Pediatric Pain (4P)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Scheduled surgery

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Queen Silvias Childrens Hospital Sahlgrenska University Hospital
  • Halmstad, Sweden, 30572
    • Hallands Hospital Halmstad
  • Helsingborg, Sweden
    • Helsingborgs hospital
  • Lund, Sweden
    • Lund childrens hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute postoperative pain	How many children experience acute postoperative pain after surgery in Sweden?	Within 24 hours after surgery
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Do regional blocks influence the level of acute postoperative pain?	Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.	Acute - within 24 hours.
Do regional blocks influence the level of persistent pain?	Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.	3 months after surgery
Parental stress	Does 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.	Within 24 hours
Parental stress	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.	3 months after surgery
Age	Which age-groups experience most pain. Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.	Acute (24 hours) and persistent (3,6 months and 1 year)
Gender	Do girls experience more pain than boys? Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.	Acute (24 hours) and persistent (3,6 months and 1 year)

Collaborators and Investigators

• Sponsor: Region Halland
• Collaborators: Lund University; Vastra Gotaland Region; Region Skane
• Investigators: Principal Investigator: Anna KM Persson, MD, PhD, Region Halland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 28, 2024
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 2022-04821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No