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NCT Number: NCT06035042

4P: Persistent Postoperative Pediatric Pain

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Silvias Childrens Hospital Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

scheduled surgery

Procedure

All subjects will be exposed to surgery

Primary outcomes

  1. Incidence of acute postoperative pain

    Time frame: Within 24 hours after surgery

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

  2. Adherence to guidelines from ESPA regarding perioperative analgesia

    Time frame: 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.

  3. Incidence of persistent postoperative pain

    Time frame: At 3 months after surgery

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

  4. Incidence of persistent postoperative pain

    Time frame: At 6 months after surgery

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

  5. Incidence of persistent postoperative pain

    Time frame: At 1 year after surgery

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

Secondary outcomes

  1. Do regional blocks influence the level of acute postoperative pain?

    Time frame: Acute - within 24 hours.

    Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.

  2. Do regional blocks influence the level of persistent pain?

    Time frame: 3 months after surgery

    Do children who recieve a regional block experience less postoperative pain? Croups compared with MannWhitney U-test.

  3. Parental stress

    Time frame: Within 24 hours

    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.

  4. Parental stress

    Time frame: 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.

  5. Age

    Time frame: 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.

  6. Gender

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Collaborators

  • Lund University
  • Region Skane
  • Vastra Gotaland Region

Registry information

Acronym: 4P

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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