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Search / Trial NCT06790719

Paediatric Breakthrough Pain Assessment

Launched by UNIVERSITY OF SOUTHAMPTON · Jan 17, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Breakthrough Pain Paediatrics Paediatric Pain Palliative Care Pain Assessment

ClinConnect Summary

This clinical trial is focused on helping children and young people who experience sudden bursts of pain, known as breakthrough pain, due to serious illnesses. Currently, there are no effective ways to measure this type of pain in younger patients, so the researchers are developing two easy-to-use questionnaires. One is for patients to fill out themselves, and the other is for parents or healthcare professionals to complete for younger children who may not be able to express their pain clearly. The goal is to improve how pain is managed in hospitals and hospices across England and Wales for patients aged 3 months to 25 years.

To participate in the study, children and young people aged 8-25 years who have been experiencing ongoing pain and are receiving regular pain relief can join, along with their parents or caregivers. Participants will help improve the questionnaires through discussions about their experiences and by providing feedback while completing the forms. The researchers will also test how well the questionnaires work to ensure they accurately measure breakthrough pain. This study aims to make things easier for young patients and their families when it comes to managing pain during difficult times.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children and young people aged 8-25 years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team (Studies 1, 2, and 3).
  • Children and young people must be able to communicate and read in English at a level close to, or in line with their chronological age.
  • For study 1, non-verbal children and young people, or those with limited verbal ability, will be recruited if they are happy to participate using the Microsoft Teams chat function.
  • Parents and caregivers of children and young people aged 3-month-25-years who have experienced 1) background pain related to a life limiting or life threatening condition and 2) around-the-clock analgesia prescribed for the previous week, as confirmed by their healthcare team. (Studies 1, 2, and 3).
  • Caregivers can be caring for verbal, non-verbal, or pre-verbal children with or without cognitive or developmental difficulties of any level.
  • Parents and caregivers must have self-reported full or partial responsibility for assessing the child or young person's pain.
  • Healthcare professionals in primary, secondary and tertiary care who are involved in the care of children and young people with life limiting or life threatening conditions (Studies 2 and 3).
  • Exclusion Criteria:
  • • Children, young people, parents and caregivers with limited ability to communicate and read in English.
  • Children and young people judged by caregivers or healthcare professionals to lack capacity to take part, who are too unwell, or might find it too distressing.
  • Parents and caregivers judged by healthcare professionals to lack capacity to consent, or to be 'struggling' too much. However, if they wish to take part, they can send an email or text message to the study email account or mobile phone.

About University Of Southampton

The University of Southampton is a leading research institution in the United Kingdom, renowned for its commitment to advancing medical and scientific knowledge. With a strong emphasis on innovation and interdisciplinary collaboration, the university conducts a wide range of clinical trials aimed at improving patient care and health outcomes. Its dedicated team of researchers and clinicians leverage cutting-edge technologies and methodologies to explore new treatments and interventions, contributing significantly to the field of healthcare. Through rigorous ethical standards and a focus on translational research, the University of Southampton strives to translate scientific discoveries into practical applications that benefit society.

Locations

Patients applied

0 patients applied

Trial Officials

Christina Liossi, DPsych

Study Chair

University of Southampton

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported