Clinical trial NCT06035042: 4P: Persistent Postoperative Pediatric Pain
Official title: 4P: Persistent Postoperative Pediatric Pain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postoperative Pain
Keywords: Pediatric pain
Lead sponsor: Region Halland
Sponsor class: OTHER
Collaborators: name: Lund University
name: Region Skane
name: Vastra Gotaland Region
First posted: 2023-09-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with planned surgery in southern Sweden for by ESPA specified types of surgeries.

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.


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.

Primary outcomes:
measure: Incidence of acute postoperative pain
timeFrame: Within 24 hours after surgery
measure: Adherence to guidelines from ESPA regarding perioperative analgesia
timeFrame: Perioperative
measure: Incidence of persistent postoperative pain
timeFrame: At 3 months after surgery
measure: Incidence of persistent postoperative pain
timeFrame: At 6 months after surgery
measure: Incidence of persistent postoperative pain
timeFrame: At 1 year after surgery
Secondary outcomes:
measure: Do regional blocks influence the level of acute postoperative pain?
timeFrame: Acute - within 24 hours.
measure: Do regional blocks influence the level of persistent pain?
timeFrame: 3 months after surgery
measure: Parental stress
timeFrame: Within 24 hours
measure: Parental stress
timeFrame: 3 months after surgery
measure: Age
timeFrame: Acute (24 hours) and persistent (3,6 months and 1 year)
measure: Gender
timeFrame: Acute (24 hours) and persistent (3,6 months and 1 year)
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Queen Silvias Childrens Hospital Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
city: Lund
country: Sweden
facility: Lund childrens hospital
Study officials:
affiliation: Region Halland
name: Anna KM Persson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: