IV iron infusion therapy in patients with persistent pain

Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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. CONDITION: Blood ‐ Anaemia Anaesthesiology ‐ Pain management Iron deficiency anaemia;Chronic pain; ; Iron deficiency anaemia ; Chronic pain PRIMARY OUTCOME: To evaluate and assess participants fatigue levels using a validated survey, the FACIT Fatigue Scale (Version 4) at baseline and then 8‐weeks post administration of derismaltose vs placebo.[8‐weeks post administration of derismaltose or placebo.] SECONDARY OUTCOME: To compare pain medication use at baseline and again 8 weeks post intervention as indicated from patient records and feedback.[8‐weeks post administration of derismaltose or placebo.] To assess health‐related quality of life by measuring 36‐Item Short Form Survey (SF‐36) (Version 1) at baseline and compare the values 8 weeks post‐intervention. ; ; ; ; [8‐weeks post administration of derismaltose or placebo.] To compare and analyse participant pain levels from baseline to 8 weeks post intervention utilising the electronic Persistent Pain Outcome Collaboration (ePPOC) questionnaire (Version 2.0). ; [8‐weeks post administration of derismaltose or placebo.] To measure iron studies parameters from baseline to 8 weeks post‐intervention from blood tests taken at both time points as an exploratory outcome. [8‐weeks post administration of derismaltose or placebo.] 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)
Epistemonikos ID: 3a976eb3aa55a9c6a293fae5259184a837f3f20a
First added on: Aug 25, 2024