Parecoxib vs. Dexketoprofen for the Management of Pain After Cesarean Section.

NCT ID: NCT04847024

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-09-30

Brief Summary

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Although it is known that parecoxib and dexketoprofen are commonly used in successful post-operative pain relief, there are very few studies that compare these two agents in their individual applications and/or combined with neuraxial analgesia with opioids and even less in post-cesarean section pain, as well as the evaluation of the side effects and their impact on the patient's functionality. For this reason, in order to approach this answer, we sought to perform this study in patients undergoing elective or emergency cesarean section in our institution, who meet the inclusion criteria, using the Visual Analog Pain Scale at 12 hrs and 24 hrs post surgery and evaluating the aforementioned side effects, comparing in one arm of the study Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in the other arm, randomizing the patients in both groups using a double-blind configuration.

Detailed Description

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Conditions

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Caesarean Section; Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in patient receiving neuraxial analgesia for pain after caesarean section.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Parecoxib

Parecoxib 40 mg reconstituted in 2ml of saline solution, to pass IV as a bolus, every 12hrs + acetaminophen 1g in 100cc of saline solution to pass IV in 15 minutes, every 6hrs.

Group Type EXPERIMENTAL

Parecoxib

Intervention Type DRUG

40 mg IV

Dexketoprofen

Dexketoprofen 50 mg in 100 cc of saline solution, protected from sunlight, to be given IV in 15 minutes, every 8hrs + acetaminophen 1g in 100 cc of saline solution to be given IV in 15 minutes, every 6hrs.

Group Type EXPERIMENTAL

Dexketoprofen

Intervention Type DRUG

50 mg IV

Interventions

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Parecoxib

40 mg IV

Intervention Type DRUG

Dexketoprofen

50 mg IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnancy 32w or more.
* Emergency or elective caesarean section.

Exclusion Criteria

* Allergy to Parecoxib.
* Allergy to dexketoprofen.
* Allergy to acetaminophen.
* General anesthesia.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Thomas H

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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2019-523

Identifier Type: -

Identifier Source: org_study_id

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