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

NCT04847024 | Completed

• 1 other identifier: 2019-523
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Caesarean Section; Pain

Keywords

Caesarean section; Pain; Parecoxib; Dexketoprofen

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Side effects

  24 hours

Study Arms (2)

Parecoxib

EXPERIMENTAL

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

Dexketoprofen

EXPERIMENTAL

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

Interventions

Parecoxib DRUG

40 mg IV

Parecoxib

Dexketoprofen DRUG

50 mg IV

Dexketoprofen

Eligibility Criteria

• Gender Eligibility Details: Gender identity
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Pain

Interventions

parecoxib; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of research

Model Details: Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in patient receiving neuraxial analgesia for pain after caesarean section.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: July 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)