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Clinical Trials/NCT06035042
NCT06035042
Completed
Not Applicable

4P: Persistent Postoperative Pediatric Pain

Region Halland5 sites in 1 country1,000 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Region Halland
Enrollment
1000
Locations
5
Primary Endpoint
Adherence to guidelines from ESPA regarding perioperative analgesia
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
January 28, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Persson

Consultant in Anaesthesia and Intensive Care Medicine, PhD

Region Halland

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Incidence of acute postoperative pain

Time Frame: Within 24 hours after surgery

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

Incidence of persistent postoperative pain

Time Frame: At 1 year after surgery

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

Incidence of persistent postoperative pain

Time Frame: At 3 months after surgery

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

Incidence of persistent postoperative pain

Time Frame: At 6 months after surgery

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

Secondary Outcomes

  • Gender(Acute (24 hours) and persistent (3,6 months and 1 year))
  • Parental stress(3 months after surgery)
  • 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)
  • Age(Acute (24 hours) and persistent (3,6 months and 1 year))
  • Parental stress(Within 24 hours)

Study Sites (5)

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