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

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Caesarean Section; Pain

Treatments: Drug: Parecoxib; Drug: Dexketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT04847024

2019-523

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Allergy to Parecoxib.
• Allergy to dexketoprofen.
• Allergy to acetaminophen.
• General anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 2 patient groups

Parecoxib

Experimental group

Description:

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.

Treatment:

Drug: Parecoxib

Dexketoprofen

Experimental group

Description:

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.

Treatment:

Drug: Dexketoprofen