Postoperative Pain4PNCT06035042
4P: Persistent Postoperative Pediatric Pain
An observational study of Postoperative Pain, run by Region Halland at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Scheduled surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Sep 2023to 28 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with planned surgery in southern Sweden for by ESPA specified types of surgeries.
Who may be able to join
- Age 1-17 years
- Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden.
- Informed consent
Who cannot join
- Scheduled for several surgeries within the time-frame
- Inability to understand swedish
- Inability to understand the meaning of participation.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Queen Silvias Childrens Hospital Sahlgrenska University Hospital
Gothenburg
Hallands Hospital Halmstad
Halmstad, 30572
Helsingborgs Hospital
Helsingborg
Lund childrens hospital
Lund
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Scheduled surgery
- Keywords
- Pediatric pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled surgeryProcedure or surgery
All subjects will be exposed to surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute postoperative pain
How many children experience acute postoperative pain after surgery in Sweden?
Measured: Within 24 hours after surgery
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.
Measured: Perioperative
Incidence of persistent postoperative pain
How many children experience persistent postoperative pain after surgery in Sweden?
Measured: At 3 months after surgery
Incidence of persistent postoperative pain
How many children experience persistent postoperative pain after surgery in Sweden?
Measured: At 6 months after surgery
Incidence of persistent postoperative pain
How many children experience persistent postoperative pain after surgery in Sweden?
Measured: At 1 year after surgery
Secondary outcomes (6)
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.
Measured: Acute - within 24 hours.
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.
Measured: 3 months after surgery
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.
Measured: Within 24 hours
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.
Measured: 3 months after surgery
Age
Which age-groups experience most pain. Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.
Measured: Acute (24 hours) and persistent (3,6 months and 1 year)
Gender
Do girls experience more pain than boys? Pain evaluated with FLACC/FPS/NRS depending on age. Risk evaluated with logistic regression.
Measured: Acute (24 hours) and persistent (3,6 months and 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion28 Sep 2024
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Halland
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Region Skane, Vastra Gotaland Region
- Responsible party
- Principal investigator, Anna Persson, Region Halland
- Investigators
- Anna KM Persson, MD, PhD, Principal investigator, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035042
- Sponsor's protocol ID
- 2022-04821
- Acronym
- 4P
- Status last verified
- Jan 2026
- First submitted
- 29 May 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Broman J, Nielsen N, Persson AKM. A prospective observational study on persistent postoperative pediatric pain, 4P: The study protocol. PLoS One. 2025 Jan 14;20(1):e0316533. doi: 10.1371/journal.pone.0316533. eCollection 2025.
PubMed 39808613
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4P: Persistent Postoperative Pediatric Pain
- ClinicalTrials.gov ID
- NCT06035042
- Acronym / sponsor ID
- 4P / 2022-04821
- Conditions
- Postoperative Pain
- Keywords
- Pediatric pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Region HallandUniversity, hospital or other
- Collaborators
- Lund University, Region Skane, Vastra Gotaland Region
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with planned surgery in southern Sweden for by ESPA specified types of surgeries.
Key inclusion criteria (3 listed)
- Age 1-17 years
- Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden.
- Informed consent
Key exclusion criteria (3 listed)
- Scheduled for several surgeries within the time-frame
- Inability to understand swedish
- Inability to understand the meaning of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled surgeryAll subjects will be exposed to surgery | Procedure or surgery | – |
Primary outcome
Incidence of acute postoperative pain
Time frame: Within 24 hours after surgery
How many children experience acute postoperative pain after surgery in Sweden?
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 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?
Incidence of persistent postoperative pain
Time frame: At 1 year after surgery
How many children experience persistent postoperative pain after surgery in Sweden?
6 secondary outcomes
Do regional blocks influence the level of acute postoperative pain?
Time frame: Acute - within 24 hours.
Do regional blocks influence the level of persistent pain?
Time frame: 3 months after surgery
Parental stress
Time frame: Within 24 hours
Parental stress
Time frame: 3 months after surgery
Age
Time frame: Acute (24 hours) and persistent (3,6 months and 1 year)
Gender
Time frame: Acute (24 hours) and persistent (3,6 months and 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 39808613Broman J, Nielsen N, Persson AKM. A prospective observational study on persistent postoperative pediatric pain, 4P: The study protocol. PLoS One. 2025 Jan 14;20(1):e0316533. doi: 10.1371/journal.pone.0316533. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna KM Persson, MD, PhD principal investigator
Region Halland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Region Halland at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute postoperative pain (time frame: Within 24 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.