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

Caesarean Section; Pain Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847024
• Other study ID #: 2019-523
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2021
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnancy 32w or more.

• Emergency or elective caesarean section.

Exclusion Criteria:

• Allergy to Parecoxib.

• Allergy to dexketoprofen.

• Allergy to acetaminophen.

• General anesthesia.

Related Conditions & MeSH terms

• Caesarean Section; Pain

Intervention

Drug:
• Parecoxib
40 mg IV
• Dexketoprofen
50 mg IV

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at 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)	12 hours
Primary	Pain at 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)	24 hours
Secondary	Side effects	Side effects associated with the drug used (Dexketoprofen vs. Parecoxib)	24 hours