Ibuprofen vs Dipyrone After C-section in Preeclampsia

NCT05586373 | Completed Phase 4

• 1 other identifier: DIPROFEN
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Preeclampsia; postpartum period; NSAIDs; acute kidney injury; cesarean section; analgesia

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Postoperative pain (mild, moderate, severe by visual analogue scale)

  from 24 after delivery to 48 hours

• Development of acute kidney injury

  Development of acute kidney injury (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).

  from 24 after delivery to 48 hours

Secondary Outcomes (26)

• Mean reduction of pain scores by visual analogue scale;

  from 24 after delivery to 48 hours

• Mean reduction in pain scores assessed by algometer

  from 24 after delivery to 48 hours

• need for rescue analgesic therapy;

  from 24 after delivery to 48 hours

• User satisfaction level

  from 24 after delivery to 48 hours

• urea dosage

  from admission in the hospital until 48 hours after delivery

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Ibuprofen 400mg 6/6h, oral, maximum 5 days

Drug: medication 1

Group 2

EXPERIMENTAL

Dipyrone 1g 6/6h, oral, maximum 5 days

Drug: medication 2

Interventions

medication 1 DRUG

Ibuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days

Also known as: Ibuprofen 400 mg

Group 1

medication 2 DRUG

Dipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days

Also known as: Dipyrone 1g

Group 2

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

IMIP

Recife, Pernambuco, 52020-070, Brazil

Location

MeSH Terms

Conditions

Pre-Eclampsia; Acute Kidney Injury; Agnosia

Interventions

Ibuprofen; Dipyrone

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 19, 2022
• Study Start: October 15, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

BR (1)