Treatment of Toddlers Fractures: Observation Or Immobilisation (TOTs)

Research Question: In children aged 9 months to 3-years diagnosed with a toddler's fracture, is no immobilisation non-inferior to immobilisation with respect to pain scores measured at 1 week by the FLACC score?

Background: Toddler's fractures are common injuries, often treated with immobilisation. Immobilisation can cause complications and affect activities. Some clinicians observe these injuries without immobilisation. There is no universally accepted treatment due to a lack of well-conducted trials. Aims and Objectives:

Objective 1 (Primary): To determine if no immobilisation is non-inferior to current management of immobilisation in this population in relation to pain by undertaking a multi-centre RCT, powered to show a 1-point non-inferiority margin on the FLACC scale at 1 week after injury.

Objective 2: To assess the feasibility of conducting a multi-centre RCT of no immobilisation vs immobilisation for toddler's fractures with an internal pilot RCT. Objective 3: To determine patients' and parents' experience and satisfaction with the two treatments.

Objective 4: To evaluate the relative cost-effectiveness of no immobilisation compared to immobilisation by undertaking a within-trial economic evaluation from both an NHS and a societal perspective. Methods

Design: Multicentre, prospective, parallel group, 1:1 randomised, pragmatic, non-blinded, non-inferiority trial with 6 week follow-up and health economic analysis. Internal pilot to assess feasibility. Setting: 20 Emergency Departments and Fracture clinics in the UK. Participants: Children aged 9 months–3-years with a radiologically confirmed toddler's fracture (