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

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.

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.

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Pain
• Intervention / Treatment: Drug: Parecoxib; Drug: Dexketoprofen

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas H

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Parecoxib; 40 mg IV
Experimental: 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.	Drug: Dexketoprofen; 50 mg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Side effects associated with the drug used (Dexketoprofen vs. Parecoxib)	24 hours

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Caesarean section; Pain; Parecoxib; Dexketoprofen
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Dexketoprofen trometamol; Parecoxib
• Other Study ID Numbers: 2019-523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No