None listed
Conditions
Brief summary
Patients with persistent or chronic pain often have underlying chronic conditions that can be overlooked such as anaemia, which can have significant effect on the quality of life of patients. A recent pilot study involving patients who have persistent pain for greater than 12 months have shown that 59% have iron deficiency. This study will follow on from the pilot study to examine if intravenous iron infusions do improve this cohort of patients fatigue levels, their health-related quality of life, pain levels and reduce pain medication use. This study will be conducted at a Quaternary hospital in Brisbane as a single-site, single-blinded, parallel-group randomised controlled trial. We plan to recruit 160 participants who will be randomised to receive either intravenous iron infusion or placebo. The outcomes will be measured using specific validated surveys and questionnaires related to fatigue (FACIT), health-related quality of life (SF-36) and pain (ePPOC).
Interventions
Patients will be booked into the surgical day care unit (SDCU) at the RBWH or the Tess Cramond Pain and Research Centre at their earliest convenience for the interventional phase of the study. The study drug will be prepared and administered by unblinded study personnel. The intervention consists of a single dose of intravenous ferric derisomaltose 20mg/kg in 100mL normal saline over 30 minutes up to a maximum dose of 1500mg. Clinical monitoring will be conducted in accordance with institutiona
Patients will be booked into the surgical day care unit (SDCU) at the RBWH or the Tess Cramond Pain and Research Centre at their earliest convenience for the interventional phase of the study. The study drug will be prepared and administered by unblinded study personnel. The intervention consists of a single dose of intravenous ferric derisomaltose 20mg/kg in 100mL normal saline over 30 minutes up to a maximum dose of 1500mg. Clinical monitoring will be conducted in accordance with institutional policies for the delivery of either the interventional arm (IV Iron) or placebo (saline) depending on randomisation allocation.
Sponsors
Metro North Health Services Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Greater than or equal to 18 years • Patients experiencing pain for more than 12 months • Patients with confirmed iron deficiency (ferritin <50u/L) with or without anaemia (Hb <120g/L for females, Hb <130g/L for males)
Exclusion criteria
Known or suspected blood disorder • Pregnant • Known medications with iron supplements including intravenous iron • Surgery within the previous 6 months • Inability to provide informed consent due to a diminished understanding or comprehension, or a language other than English without an interpreter
Outcome results
None listed