Feasibility trial assessing the management of acute pain in children and young people attended by ambulance using the PANDA intervention

Improving Pain mAnagement for childreN and young people attendeD by Ambulance (PANDA): a pragmatic cluster randomised feasibility trial assessing standard care plus the PANDA Intervention versus standard care to reduce pain severity for children and young people attended by paramedics

Registry ID
ISRCTN13615304
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
East Midlands Ambulance Service NHS Trust
Enrollment
120
Start date
2026-06-01
Completion date
2027-02-28
Last update
2026-08-17

Conditions

Summary

Pain management

Detailed description

We will recruit 30 paramedics and randomise them to provide standard care, or standard care plus the PANDA Intervention. The PANDA Intervention aims to change the behaviour of ambulance clinicians by giving them more knowledge and confidence, making them more prepared to manage children and young people in pain. The intervention contains: 1. An education and training package 2. A system of feedback 3. A pocket prompt sheet 4. A distraction kit containing bravery stickers and sensory toys that the paramedic can use at their discretion to enhance the patient-clinician relationship and build trust Follow up surveys: Will ask about any ongoing pain since the ambulance attendance, sleep disturbance (completed by the parent/carer) and risk of post-traumatic stress disorder (completed by 8+ year old children and young people). The survey will also ask about the most positive and negative memory of the event. Survey completion should take no more than 10 minutes. Interviews: Will be conducted online, via telephone, or face to face, as preferred, at a date/time to suit the participant. We will ask about their experience of care and how acceptable being part of the study is. For younger children we will use arts/crafts and toy ambulances when face to face to facilitate the experience-sharing process. Interviews will be audio recorded. Data analysis: Qualitative data will be analysed thematically. Quantitative data will be analysed descriptively. This feasibility trial will enable us to perform a sample size calculation for a future trial, including estimating the Intracluster Correlations Coefficient.

Interventions

Inclusion criteria

Paramedics (inclusion criteria to be randomised): 1. Employed by East Midlands Ambulance Service NHS Trust 2. Registered as a paramedic with the Health and Care Professions Council 3. Working full-time 4. Working entirely in a frontline face to face clinical role Children and young people (inclusion criteria for feasibility trial enrolment): 1. Children and young people aged under 18 years of age 2. Suffering acute pain (initial pain score above zero) 3. Attended by an EMAS PANDA Feasibility Trial paramedic 4. The EMAS PANDA Feasibility Trial paramedic had active involvement in the management of the pain Children and young people (inclusion criteria for qualitative interviews): 1. Enrolled in the PANDA Feasibility Trial 2. Aged 4–18 years Children and young people (inclusion criteria for survey follow-up): 1. Enrolled in the PANDA Feasibility Trial 2. Aged 3–18 years Parents/carers (inclusion criteria for qualitative interviews): Aged 16 years and above

Exclusion criteria

Children and young people (exclusion criteria for feasibility trial enrolment): 1. CYP in Young Offender Institutions (YOIs), Secure Training Centres, or Secure Children’s Homes 2. CYP suffering major trauma (as per locally agreed definition) or critical illness, including the following conditions: cardiac arrest, sepsis, seizure, heart attack, stroke, anaphylaxis, life-threatening asthma

Locations

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