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Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study
- Source :
- Pilot and Feasibility Studies, Pilot and Feasibility Studies, Vol 5, Iss 1, Pp 1-13 (2019)
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- Background In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible. Methods Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture. Results We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics’ recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 (n = 20) versus 3.5 (n = 13) for usual care. Conclusions RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture. Trial registration ISRCTN 60065373 sought 5 November 2015. Electronic supplementary material The online version of this article (10.1186/s40814-019-0454-1) contains supplementary material, which is available to authorized users.
- Subjects :
- Randomised trial
medicine.medical_specialty
Cost effectiveness
Medicine (miscellaneous)
Feasibility study
Hip fracture
03 medical and health sciences
0302 clinical medicine
Patient satisfaction
Quality of life
medicine
Pre-hospital
Paramedic
030212 general & internal medicine
Adverse effect
Trial Arms
lcsh:R5-920
business.industry
Research
medicine.disease
Focus group
Fractured neck of femur
Usual care
Physical therapy
Analgesia
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
Fascia iliaca compartment block
Subjects
Details
- ISSN :
- 20555784
- Volume :
- 5
- Database :
- OpenAIRE
- Journal :
- Pilot and Feasibility Studies
- Accession number :
- edsair.doi.dedup.....6c152829575a42b05008fadd28a810e7