Complex regional pain syndrome
Conditions
Brief summary
Pain intensity measured by Numerical Rating Scale (NRS). The current NRS score reflecting the pain intensity at the moment when asked and the average NRS score of the last 24 hours. (T0, T3, T4)
Detailed description
To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients. (T1, T2), Number and severity of intervention related adverse events: Psychomimetic (dysphoria, euphoria, hallucinations, nightmares and vivid dreams, anxiety, agitation), blurry vision or diplopia, nausea and / or vomiting, sedation, hepatic toxicity, headache and dislocation of peripheral intravenous catheter (T1, T2), Number of administered co-interventions related to adverse events (benzodiazepines, clonidine, granisetron). (T1), NRS pain scores over time till follow-up T3. The current NRS score reflecting the pain intensity at the moment when asked by telephone and the average NRS score of the last 24 hours. (T1, T2), Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with Enzyme Linked Immunosorbent Assay (ELISA) as measures for T-lymphocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry. (T0, T3), To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing (T0, T3), Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography (T0, T3), Dose reduction of pain medication at follow after three months and six months (T3, T4), CRPS symptoms and signs based on the Budapest diagnostic clinical criteria; CRPS severity score (20). (T0, T3), Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies) (42, 43):
Interventions
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured by Numerical Rating Scale (NRS). The current NRS score reflecting the pain intensity at the moment when asked and the average NRS score of the last 24 hours. (T0, T3, T4) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients. (T1, T2), Number and severity of intervention related adverse events: Psychomimetic (dysphoria, euphoria, hallucinations, nightmares and vivid dreams, anxiety, agitation), blurry vision or diplopia, nausea and / or vomiting, sedation, hepatic toxicity, headache and dislocation of peripheral intravenous catheter (T1, T2), Number of administered co-interventions related to adverse events (benzodiazepines, clonidine, granisetron). (T1), NRS pain scores over time till follow-up T3. The current NRS score reflecting the pain intensity at the moment when asked by telephone and the average NRS score of the last 24 hours. (T1, T2), Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with E | — |
Countries
Netherlands
Outcome results
None listed