Clinical trial NCT05586373: Ibuprofen vs Dipyrone After C-section in Preeclampsia
Official title: Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: Preeclampsia
postpartum period
NSAIDs
acute kidney injury
cesarean section
analgesia
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 74
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Specific objectives

In postpartum women with preeclampsia undergoing cesarean section randomized to receive treatment with ibuprofen versus dipyrone for postoperative analgesia, compare:

primary outcomes

1. Postoperative pain (mild, moderate, severe by visual analogue scale)
2. 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).

secondary outcomes

1. Average reduction of visual analogue scale scores;

2 Reduction of mean scores by algometer;

3. Need for rescue analgesic;

4. User satisfaction with the Likert scale;

5. Basic laboratory tests and their evolution: urea, creatine, uric acid, saline, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and plaque;

6. Evolution of blood pressure in the puerperium;

7. Number of hypertensive peaks;

8. Need for maintenance antihypertensive treatment and number of drugs;

9. Allergic reactions;

10. Gastrointestinal side effects;

11. Time between postoperative and unassisted ambulation;

12. Length of hospital stay;

13. Compound maternal morbidity (eclampsia, acute weight edema, HELLP, difficulty hypertension, intracranial hemorrhage, renal function control and others);

14. Maternal death;

15. Costs related to analgesic medications.

The sample is 74 patients randomized into two groups: one group that will receive dipyrone and the other group that will receive ibuprofen. Randomization for the two groups will be performed according to a list of random numbers drawn up for that purpose by an employee who does not be involved with data collection, to ensure confidentiality in the allocation. From this list, sealed envelopes will be prepared, numbered sequentially, with each number, according to the randomization table, corresponding to the patient's group (dipyrone or ibuprofen).

For statistical analysis of the data, the domain statistical program will be used public Epi-info version 7, or higher versions. Tables will be distributed frequency distribution for categorical variables, calculating the mean and standard deviation of quantitative variables. Then, contingency tables will be used to determine the association of the independent variable (Ibuprofen versus dipyrone) with the dependent variables (Biological characteristics, obstetric features, Maternal clinical parameters at admission and during hospitalization, Maternal laboratory tests at the time of admission). For determination of the strength of association will be calculated as a measure of the risk (RR) and its 95% confidence interval. All p values will be two-tailed and in all stages of the analysis will be considered a level of significance 5%.

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;

Primary outcomes:
measure: Postoperative pain
timeFrame: from 24 after delivery to 48 hours
measure: Development of acute kidney injury
timeFrame: from 24 after delivery to 48 hours
Secondary outcomes:
measure: Mean reduction of pain scores by visual analogue scale;
timeFrame: from 24 after delivery to 48 hours
measure: Mean reduction in pain scores assessed by algometer
timeFrame: from 24 after delivery to 48 hours
measure: need for rescue analgesic therapy;
timeFrame: from 24 after delivery to 48 hours
measure: User satisfaction level
timeFrame: from 24 after delivery to 48 hours
measure: urea dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: aspartate transferase dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: potassium dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: chlorine dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: alanine transferase dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: lactic dehydrogenase dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: sodium dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: creatinine dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: c
timeFrame: from admission in the hospital until 48 hours after delivery
measure: total and fractions bilirubin dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: uric acid dosage
timeFrame: from admission in the hospital until 48 hours after delivery
measure: Evolution of blood pressure in the puerperium
timeFrame: from 24 after delivery to 48 hours
measure: Number of hypertensive peaks
timeFrame: from 24 after delivery until discharge of the hospital
measure: need for maintenance antihypertensive treatment
timeFrame: from 24 after delivery until discharge of the hospital
measure: number of antihypertensive drugs;
timeFrame: from 24 after delivery until discharge of the hospital
measure: Allergic reactions
timeFrame: from 24 after delivery to 48 hours
measure: Gastrointestinal side effects
timeFrame: from 24 after delivery to 48 hours
measure: Time between postoperative and unassisted ambulation
timeFrame: from 24 after delivery to 48 hours
measure: Length of hospital stay
timeFrame: From hospital admission to hospital discharge date or up to eight days after surgery whichever comes first.
measure: Compound maternal morbidity
timeFrame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
measure: Maternal death
timeFrame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
measure: Costs related to analgesic medications
timeFrame: from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
Study officials:
References: