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

Not Applicable

Completed

• Conditions: Caesarean Section; Pain
• Interventions: Drug: Parecoxib; Drug: Dexketoprofen

• Registration Number: NCT04847024
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 380

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parecoxib	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.
Dexketoprofen	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.

Primary Outcome Measures

Name	Time	Method
Pain at 12 hours	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)
Pain at 24 hours	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 Outcome Measures

Name	Time	Method
Side effects	24 hours	Side effects associated with the drug used (Dexketoprofen vs. Parecoxib)

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama