Ibuprofen vs Dipyrone After C-section in Preeclampsia

Preeclampsia Clinical Trial

— DIPROFEN  

Official title:

Use of Ibuprofen Versus Dipyrone in Preeclampsia Submitted to C-section: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586373
• Other study ID #: DIPROFEN
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• medication 1
Ibuprofen pills, identical to the intervention (dipyrone pills), will be administered every 6 hour for a maximum of five days
• medication 2
Dipyrone pills, identical to the intervention (ibuprofen pills), will be administered every 6 hour for a maximum of five days

Locations

Country	Name	City	State
Brazil	IMIP	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain (mild, moderate, severe by visual analogue scale)	from 24 after delivery to 48 hours
Primary	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	Mean reduction of pain scores by visual analogue scale;	Mean reduction of pain scores by visual analogue scale;	from 24 after delivery to 48 hours
Secondary	Mean reduction in pain scores assessed by algometer	Mean reduction in pain scores assessed by algometer	from 24 after delivery to 48 hours
Secondary	need for rescue analgesic therapy;	Quantify the number of times analgesic medication was requested, in addition to what is being offered in the study	from 24 after delivery to 48 hours
Secondary	User satisfaction level	Likert scale, used in questionnaires, Participants choose from a variety of possible responses to a specific question or statement; responses usually include "strongly agree", "agree", "neutral", "disagree" and "strongly disagree".	from 24 after delivery to 48 hours
Secondary	urea dosage	Baseline laboratory tests and their evolution, urea measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	aspartate transferase dosage	Baseline laboratory tests and their evolution, aspartate transferase dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	potassium dosage	Baseline laboratory tests and their evolution, potassium dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	chlorine dosage	Baseline laboratory tests and their evolution,chlorine dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	alanine transferase dosage	Baseline laboratory tests and their evolution, alanine transferase dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	lactic dehydrogenase dosage	Baseline laboratory tests and their evolution, lactic dehydrogenase dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	sodium dosage	Baseline laboratory tests and their evolution, sodium dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	creatinine dosage	Baseline laboratory tests and their evolution, creatinine dosage measured in mg/dl at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	c	Baseline laboratory tests and their evolution, creatinine dosage measured in mm³ at admission and up to 48 hours after admission.	from admission in the hospital until 48 hours after delivery
Secondary	total and fractions bilirubin dosage	Baseline laboratory tests and their evolution: urea, creatinine, uric acid, sodium, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and platelets;	from admission in the hospital until 48 hours after delivery
Secondary	uric acid dosage	Baseline laboratory test and the evolution. urea, creatinine, uric acid, sodium, potassium and chlorine, lactic dehydrogenase (DHL), aspartate transferase (AST), alanine transferase (ALT), total and fractions bilirubin and platelets;	from admission in the hospital until 48 hours after delivery
Secondary	Evolution of blood pressure in the puerperium	Evolution of blood pressure in the puerperium	from 24 after delivery to 48 hours
Secondary	Number of hypertensive peaks	Number of hypertensive peaks (systolic blood pressure of 180mmHg and/or diastolic blood pressure of 120mmHg);	from 24 after delivery until discharge of the hospital
Secondary	need for maintenance antihypertensive treatment	Identify the presence or absence of maintenance antihypertensive drugs	from 24 after delivery until discharge of the hospital
Secondary	number of antihypertensive drugs;	quantify how many antihypertensive medications are being used	from 24 after delivery until discharge of the hospital
Secondary	Allergic reactions	Questionnaire with options for allergic manifestations: urticaria, angioedema, eczema, asthma.	from 24 after delivery to 48 hours
Secondary	Gastrointestinal side effects	Questionnaire with options for acute gastrointestinal effects: abdominal pain, dyspepsia and diarrhea	from 24 after delivery to 48 hours
Secondary	Time between postoperative and unassisted ambulation	Time between postoperative and unassisted ambulation	from 24 after delivery to 48 hours
Secondary	Length of hospital stay	Length of hospital stay	From hospital admission to hospital discharge date or up to eight days after surgery whichever comes first.
Secondary	Compound maternal morbidity	Compound maternal morbidity (eclampsia, acute pulmonary edema, HELLP syndrome, difficult-to-control hypertension, intracranial hemorrhage, renal failure and others);	from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Secondary	Maternal death	Space reserved in the questionnaire to be described according to the death certificate the primary cause of maternal death.	from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.
Secondary	Costs related to analgesic medications	Accounting for the cost related to each dose doses of anesthetic medications that were used in addition to the therapeutic regimens of the experiment were used	from 24 after delivery until discharge date or up to eight days after surgery whichever comes first.