4P: Persistent Postoperative Pediatric Pain

Postoperative Pain Clinical Trial

— 4P  

Official title:

4P: Persistent Postoperative Pediatric Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035042
• Other study ID #: 2022-04821
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Region Halland
• Contact: Anna KM Persson, MD. PhD
• Phone: +4635131676
• Email: anna.p.persson[@]regionhalland.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 28, 2025
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Scheduled surgery
All subjects will be exposed to surgery

Locations

Country	Name	City	State
Sweden	Queen Silvias Childrens Hospital Sahlgrenska University Hospital	Göteborg
Sweden	Hallands Hospital Halmstad	Halmstad
Sweden	Helsingborgs Hospital	Helsingborg
Sweden	Lund childrens hospital	Lund

Sponsors (4)

Lead Sponsor	Collaborator
Region Halland	Lund University, Region Skane, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute postoperative pain	How many children experience acute postoperative pain after surgery in Sweden?	Within 24 hours after surgery
Primary	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
Primary	Incidence of persistent postoperative pain	How many children experience persistent postoperative pain after surgery in Sweden?	At 3 months after surgery
Primary	Incidence of persistent postoperative pain	How many children experience persistent postoperative pain after surgery in Sweden?	At 6 months after surgery
Primary	Incidence of persistent postoperative pain	How many children experience persistent postoperative pain after surgery in Sweden?	At 1 year after surgery
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)