4P: Persistent Postoperative Pediatric Pain

• Sponsor: Region Halland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06035042
• Collaborator: Lund University (Other), Region Skane (Other), Sahlgrenska University Hospital, Sweden (Other)
• Enrollment: 2,000
• Locations: 4
• Anticipated Duration (Months): 17.9
• Patients Per Site: 500
• Patients Per Site Per Month: 27.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Scheduled surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 4P: Persistent Postoperative Pediatric Pain
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Feb 28, 2025

Outcome Measures

Primary Outcome Measures

1. Incidence of acute postoperative pain [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 [Perioperative]

   Are the suggested guidelines regarding pain treatment from ESPA followed and is that successful?

3. Incidence of persistent postoperative pain [At 3 months after surgery]

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

4. Incidence of persistent postoperative pain [At 6 months after surgery]

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

5. Incidence of persistent postoperative pain [At 1 year after surgery]

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

Secondary Outcome Measures

1. Do regional blocks influence the level of acute postoperative pain? [Acute - within 24 hours.]

   Does the use of regional blocks affect acute postoperative pain?

2. Do regional blocks influence the level of persistent pain? [3 months after surgery]

   Does the use of regional blocks affect persistent postoperative pain?

3. Parental stress [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?

4. Parental stress [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?

5. Age [Acute (24 hours) and persistent (3,6 months and 1 year)]

   Which age-groups experience most pain

6. Gender [Acute (24 hours) and persistent (3,6 months and 1 year)]

   Do girls experience more pain than boys?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Silvias Childrens Hospital Sahlgrenska University Hospital	Göteborg		Sweden
2	Hallands Hospital Halmstad	Halmstad		Sweden	30572
3	Helsingborgs Hospital	Helsingborg		Sweden
4	Lund childrens hospital	Lund		Sweden

Sponsors and Collaborators

• Region Halland
• Lund University
• Region Skane
• Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Anna KM Persson, MD, PhD, Region Halland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Persson, MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine, Region Halland
• ClinicalTrials.gov Identifier: NCT06035042
• Other Study ID Numbers: 2022-04821
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anna Persson, MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine, Region Halland: Pediatric pain
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Sep 13, 2023