Clinical trial
Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial
Name
DIPROFEN
Description
The goal of this randomized, triple-masked clinical trial is to compare the effectiveness and safety of the use of ibuprofen versus dipyrone for postoperative analgesia in postpartum women with preeclampsia undergoing cesarean section.
The main question it aims to answer are:
* Postoperative pain is similar;
* The frequency of acute kidney injury is similar.
Researchers will compare one group that will receive dipyrone and the other group that will receive ibuprofen to see if Postoperative pain are different between groups or development of acute kidney injury each group is different.
Trial arms
Trial start
2022-10-15
Estimated PCD
2023-05-31
Trial end
2023-05-31
Status
Completed
Phase
Early phase I
Treatment
medication 1
Ibuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days
Arms:
Group 1
Other names:
Ibuprofen 400 mg
medication 2
Dipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days
Arms:
Group 2
Other names:
Dipyrone 1g
Size
74
Primary endpoint
Postoperative pain
from 24 after delivery to 48 hours
Development of acute kidney injury
from 24 after delivery to 48 hours
Eligibility criteria
Inclusion Criteria:
* Puerperal women from 14 years of age diagnosed with preeclampsia with signs of severity Immediate postoperative period;
* Delivery attended at the Maternity from Instituto de Medicina Integral Prof Fernando Figueira.
Exclusion Criteria:
* Acute kidney disease (serum creatinine 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or decrease in urine output to \<0.5 mL/kg/hour for six to 12 hours)
* Chronic kidney disease;
* Diabetes mellitus;
* Collagenoses;
* Sickle cell anemia;
* Patients who presented bleeding in the pre, trans and immediate postpartum periods;
* Antepartum or puerperal sepsis;
* Known contraindications to the use of NSAIDs and dipyrone;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2023-06-09
1 organization
2 products
1 indication
Product
Medication 1Indication
PreeclampsiaProduct
3D1002