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Assessment of acute limp or joint pain in children presenting to emergency departments.

Paediatric Acute Limp Study (PALS) - A prospective observational cohort study to derive and validate a new paediatric limp / lower limb pain clinical decision rule for optimal evaluation of acute non-traumatic lower limb pain / limp in children presenting to the emergency department.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000968370
Acronym
PALS
Enrollment
9000
Registered
2026-08-06
Start date
2026-08-31
Completion date
2029-08-31
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Limb pain in children is common. While often harmless, it can sometimes be caused by serious conditions like infections, cancer, or rheumatic fever. Right now, it’s hard to know which children need urgent tests and which don’t. A good decision-making tool could help doctors make faster, safer, and more cost-effective choices. This study is looking at children who come to the emergency department (ED) with sudden limb pain (like a sore arm or leg or with a limp). The goal of the project is to either validate an existing Clinical Decision Rule (CDR) or create and test a new CDR that helps doctors quickly and safely decide which children might have a serious condition and need further tests like blood work or scans - and which children don’t. This prospective observational study will collect data prior to clinical treatment or investigation of children aged <16 years presenting to the ED with acute onset (within the last 7 days) of non-traumatic limb pain and/or limp at 18 EDs in Australia and New Zealand who are part of the PREDICT research network. This study aims to derive and validate a paediatric ED Clinical Decision Rule (PAL CDR) that (i) accurately detects serious pathology bone and joint infection, malignancy, slipped upper femoral epiphysis, ARF) and (ii) risk-stratifies children with suspected serious pathology* into those who do and do not require blood tests or imaging. Primary Aim: To derive and validate a paediatric ED CDR that (i) accurately detects serious pathology (bone and joint infection, malignancy, acute rheumatic fever (ARF), slipped upper femoral epiphysis) and (ii) risk-stratifies children with suspected serious pathology into those who do and do not require blood tests or imaging. Secondary Aims: (1) To externally validate, in ANZ EDs, current overseas-derived CDRs by assessing (i) the accuracy of detecting confirmed serious pathology; (ii) the ability to accurately identify children who do not need blood tests or imaging investigations; (iii) cost-effectiveness of different CDRs. (2) To determine the performance of the newly derived and established CDRs in settings with low and high prevalence of ARF.

Interventions

This study aims to derive and validate a paediatric ED Clinical Decision Rule (PAL CDR) that (i) accurately detects serious pathology bone and joint infection, malignancy, slipped upper femoral epiphysis, ARF) and (ii) risk-stratifies children with suspected serious pathology* into those who do and do not require blood tests or imaging. The CDR will not be used to guide patient care during this study. Instead, the study aims to derive and validate the rule and evaluate how it could potentially i

This study aims to derive and validate a paediatric ED Clinical Decision Rule (PAL CDR) that (i) accurately detects serious pathology bone and joint infection, malignancy, slipped upper femoral epiphysis, ARF) and (ii) risk-stratifies children with suspected serious pathology* into those who do and do not require blood tests or imaging. The CDR will not be used to guide patient care during this study. Instead, the study aims to derive and validate the rule and evaluate how it could potentially influence future decisions about blood tests and imaging. Data will be collected prospectively at the time of ED presentation and retrospectively (30-60 days and 6 months) after ED presentation. • Prospective audit, recording routinely collected clinical assessment data: At the time of ED presentation the treating clinician will collect predictor variables; -Patient History: duration of pain, temperature, medications, history of trauma or illness in previous 2-4 weeks, previous bone/joint problems. - Examination findings - Clinical impression - POCUS findings (if performed) •Retrospective review of the medical record: At 30-60 days, and 6 months after ED presentation, the research team will collect the following variables via chart review; - Basic demographic/ED presentation data - Vital signs and pain scores - Clinical notes: location of pain, systemic symptoms, past medical history, ED disposition, mobility at discharge, outpatient follow up - Radiology results - Pathology results - Treatment in ED - Diagnosis Participant data such as quality of life, ongoing symptoms, health service use, diagnoses, representations to hospital, treatment, procedures and test results will be collected via questionnaire; - On enrolment - 30-60 days after ED visit - 6 months after ED visit

Sponsors

Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
0 to 15 Years
Healthy volunteers
No

Inclusion criteria

Children aged <16 years presenting to the ED with acute onset (within the last 7 days) of non-traumatic lower limb pain and/or limp.

Exclusion criteria

• Children who present with a history of trauma where the symptoms were maximal at the time of the trauma (i.e. traumatic limb pain). This will be operationalised as “Acute trauma (e.g. clear injury with immediate pain such as fall / direct blow) directly leading to ED visit.” • Known chronic joint problem affecting the same limb (e.g. previously diagnosed chronic arthritis, Perthes disease, slipped upper femoral epiphysis) • Unable to obtain an accurate history (e.g. parent / guardian unavailable, language other than English and no interpreter available) • Child is in out of home care and staff are unable to obtain consent from appropriate carer / guardian

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 25, 2026