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Dipyrone for the acute treatment of Dialysis Headache

Evaluation of Dipyrone in the acute treatment of Dialysis Headache: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-3sdgfyy
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-06-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

Interventions

This is a double-blind randomized clinical trial with a control group. Patients will be randomized into two groups: Dipyrone Group: will receive an intravenous injection with a solution containing one
2. Visual Analog Pain Scale
3. Medication Global Rating Verbal Scale and Adverse Effects Questionnaire. To calculate the sample size, a pilot study will be carried out with the first 40 headache attacks presented by patients (20

Sponsors

Pós Graduação em Neuropsiquiatria e Ciências do Comportamento - Universidade Federal de Pernambuco
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both genders; aged 18 years or over; on hemodialysis treatment for chronic renal failure; diagnosed with dialysis headache according to the criteria of the International Classification of Headache Disorders (ICHD-3); who experience this headache during dialysis

Exclusion criteria

Exclusion criteria: Patients who have a known diagnosis of Acute Chronic Renal Failure; patients who are allergic to dipyrone

Design outcomes

Primary

MeasureTime frame
Percentage of patients who were free of pain after 02 hours of administration of the intervention.

Secondary

MeasureTime frame
Percentage of patients who improved their pain after 02 hours (decrease in pain from moderate to severe (5 to 7 points) at baseline to mild or no pain (0 to 4 points) after 2 hours of administration of the intervention.;Time to obtain significant pain relief and complete improvement;Percentage of patients with sustained headache relief – patients who were pain-free after 2 hours of the intervention and who had no recurrence or need for rescue medication for pain in the first 24 hours after the intervention;Global evaluation of the patient in relation to the intervention.;Incidence of adverse effects

Countries

Brazil

Contacts

Public ContactPedro Sampaio Rocha-Filho

Universidade Federal de Pernambuco

pedro.rochafilho@ufpe.br+55 081 21268523

Outcome results

None listed

Source: REBEC (via WHO ICTRP)