unspecified pain
Conditions
Interventions
Outpatient and / or hospital care data from approximately 335,000 participants with at least one record of metamizole use (as a single drug or associations) in the Amil CDW database between January 20
L01.224.050.375.580
Sponsors
Sanofi-Aventis Farmacêutica Ltda.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1: metamizole-based cohort Any patient active in the system with at least one record of metamizole prescription during the study period. Cohort 2: symptoms-based cohort -Any active patient in the system with at least one record of headache, migraine or fever between December 1, 2016 and March 31, 2017 or between May 1, 2017 and August 31, 2017.
Exclusion criteria
Exclusion criteria: Cancer (oncology patients under treatment during the period of the study); Rheumatic and autoimmune disorders (Rheumatoid arthritis, Ankylosing spondylitis, Crohn’s disease, Ulcerative colitis, Psoriasis or psoriatic arthritis, Lupus, Fibromyalgia, Osteoarthritis); Pregnancy (during the period of the study, not including c-section post-operative use, i.e., metamizole use post-delivery will be included); History of metamizole allergy, including anaphylactic reactions; Haematological history: bone marrow dysfunction; Deficiency of glucose-6-phosphate dehydrogenase (G6PD); Had an invalid Amil member identification; Denied having used the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate which types of pain metamizole was used as a single drug or in association verified through NLP in medical records;Assess whether metamizole was prescribed as a single drug or in combination for fever relief verified through NLP in medical records | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic profile of the population using metamizole (age, gender, state / region); ;Patients who used metamizole as an isolated drug or associations in the hospital and outpatient setting;;mean Pain intensity before use of metamizole (in patients who used it for pain) assessed with analogic visual scale;Number of Patients who presented a reduction in temperature with the use of metamizole (in patients who used it for fever) in the hospital context; ;Number of Painkillers used before, concomitantly and after use of metamizole; ;Dosage in each form of administration (oral, injectable, suppository) of metamizole and interval between doses (if multiple doses); ;Dosage of metamizole and other non-opioid analgesics used in patients who used metamizole; ;Number of outpatient consultations per patient; ;Number of Associated comorbidities present in patients who used metamizole. | — |
Countries
Brazil
Contacts
Public ContactWanessa Scala
Sanofi-Aventis Farmacêutica Ltda.
Outcome results
None listed