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OpenTrials
Completed

NCT Number: NCT04847024

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H

Panama City, Panama

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Parecoxib

Drug

40 mg IV

Dexketoprofen

Drug

50 mg IV

Primary outcomes

  1. Pain at 12 hours

    Time frame: 12 hours

    Evaluation of pain using the Visual Analogue Scale (from 0 to 10, where 0 is no pain and 10 is the most terrible pain imaginable)

  2. Pain at 24 hours

    Time frame: 24 hours

    Evaluation of pain using the Visual Analogue Scale (from 0 to 10, where 0 is no pain and 10 is the most terrible pain imaginable)

Secondary outcomes

  1. Side effects

    Time frame: 24 hours

    Side effects associated with the drug used (Dexketoprofen vs. Parecoxib)

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Parecoxib vs. Dexketoprofen in Combination With Acetaminophen as Additional Analgesia in Patients With Neuraxial Morphine for the Management of Pain After Cesarean Section. A Randomized, Double Blind, Controlled Trial.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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